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This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.
The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric and thoracic staple line reinforcement | Experimental | ECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staple Line Reinforcement | Device | ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures | Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line). | From Day 0 (day of surgery) through 70 days post-surgery |
| Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days | Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema). | From Day 0 (day of surgery) through 70 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Devices Replaced During Surgery | Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported. | Day 0 (Intra-surgery) |
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Inclusion Criteria:
Primary procedure (gastric or lung resection) where the ECHELON SLR is planned to be used for reinforcement of staple lines per the IFU in either a or b:
Willingness to give consent and comply with all study-related evaluations and visit schedule; and
At least 18 years of age.
Exclusion Criteria:
- Preoperative:
Physical or psychological condition which would impair study participation;
Body mass index (BMI) ≥ 46.0 kg/m2;
The procedure is a revision/reoperation for the same indication or same anatomical location;
A procedure where extended wound or organ support is required;
Any medical condition that the investigator deems could impact inflammatory or immune response;
Concurrent treatment with medications that the investigator deems could have influence on wound healing;
History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or
Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Popoff, MD | Henry Ford Health System | Principal Investigator |
| David Zeltsman, MD | Long Island Jewish Medical Center | Principal Investigator |
| Andrew Wheeler, MD | University of Missouri-Columbia | Principal Investigator |
| Jon Schram, MD | Corewell Health West | Principal Investigator |
| Kenneth Kesler, MD | Indiana University Health | Principal Investigator |
| Emily Cassidy, MD | Our Lady of the Lake Hospital | Principal Investigator |
| Keith Gersin, MD | Wake Forest University Health Sciences | Principal Investigator |
| Linda Martin, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health | Indianapolis | Indiana | 46202 | United States | ||
| Our Lady of the Lake Regional Medical Center |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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Participants were screened anytime during a period of 8 weeks prior to the date of surgery.
Participants who planned to have an elective gastric or lung resection surgical procedure were recruited in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gastric Participants | Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. |
| FG001 | Thoracic Participants | Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gastric Participants | Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. |
| BG001 | Thoracic Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures | Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line). | The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. Here, N' (number of participants analyzed) signifies the participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for specified arm only. | Posted | Count of Participants | Participants | From Day 0 (day of surgery) through 70 days post-surgery |
From Day 0 (Day of surgery) up to end of the study (2 years 4 months)
The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gastric Participants | Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SENIOR DIRECTOR OF CLINICAL AFFAIRS | Ethicon Endo-Surgery | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2021 | Oct 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2022 | Oct 17, 2023 | SAP_001.pdf |
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| Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback |
Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response was ranged from 1 to 5 where 1=strongly disagree, 2=slightly disagree,3=neutral, 4=slightly agree, 5= strongly agree, where the higher response signified good experience on the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and 5th procedure were reported. |
| Day 0 (Intra-surgery) |
| Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device" and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and fifth procedure were reported. | Day 0 (Intra-surgery) |
| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| University of Missouri | Columbia | Missouri | 65201 | United States |
| Long Island Jewish Medical Center | New York | New York | 11040 | United States |
| Atrium Health | Charlotte | North Carolina | 28203 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Withdrawal by Subject |
|
| Other |
|
Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Gastric Participants | Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. |
|
|
| Primary | Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days | Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema). | The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. This outcome measure was planned to be analyzed for specified arm only. | Posted | Count of Participants | Participants | From Day 0 (day of surgery) through 70 days post-surgery |
|
|
|
| Secondary | Number of Study Devices Replaced During Surgery | Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported. | The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure. | Posted | Number | Replaced study devices | Day 0 (Intra-surgery) | Study devices | Study devices |
|
|
|
| Secondary | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response was ranged from 1 to 5 where 1=strongly disagree, 2=slightly disagree,3=neutral, 4=slightly agree, 5= strongly agree, where the higher response signified good experience on the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and 5th procedure were reported. | The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies the number of investigators who responded to device questionnaire. | Posted | Number | Investigators | Day 0 (Intra-surgery) |
|
|
|
| Secondary | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device" and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and fifth procedure were reported. | The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure. Here, N' (number of participants analyzed) signifies the number of investigators who responded to device questionnaire. | Posted | Number | Investigators | Day 0 (Intra-surgery) |
|
|
|
| 0 |
| 109 |
| 8 |
| 109 |
| 74 |
| 109 |
| EG001 | Thoracic Participants | Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. | 2 | 131 | 18 | 131 | 116 | 131 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastric Fistulas | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Fungaemia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Drain site complication | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastrointestinal anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Short-bowel syndrome | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Abdominal fat apron | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastric fistula | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastric perforation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Reflux gastritis | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Postoperative delirium | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Drain site complication | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Gastrointestinal anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Hepatic rupture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Post-thoracotomy pain syndrome | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA Version 22.0 | Systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Fungaemia | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Administration site swelling | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pneumopericardium | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
|
| Thoracic cavity drainage test abnormal | Investigations | MedDRA Version 22.0 | Systematic Assessment |
|
| Chest X-ray | Investigations | MedDRA Version 22.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA Version 22.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
|
Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
| Not Loaded Properly |
|
| Other - Preloaded Wrong Color Cartridge |
|
| Other- SLR Added Before Cartridge |
|
| Other- Dropped on the Ground |
|
| Experienced less buttress manipulation and movement compared to previous buttress: Neutral |
|
| Experienced less buttress manipulation and movement compared to previous buttress: Slightly agree |
|
| Experienced less buttress manipulation and movement compared to previous buttress: Strongly agree |
|
| Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly disagree |
|
| Greater confidence that SLR buttress deliver best outcomes compared to previous:Slightly disagree |
|
| Greater confidence that SLR buttress deliver best outcomes compared to previous: Neutral |
|
| Greater confidence that SLR buttress deliver best outcomes compared to previous: Slightly agree |
|
| Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly agree |
|
| SLR setup simplifies concerns compared to previous buttress product: Strongly disagree |
|
| SLR setup simplifies concerns compared to previous buttress product: Slightly disagree |
|
| SLR setup simplifies concerns compared to previous buttress product: Neutral |
|
| SLR setup simplifies concerns compared to previous buttress product: Slightly agree |
|
| SLR setup simplifies concerns compared to previous buttress product: Strongly agree |
|
| Surgical staff experienced less frustration with SLR compared to previous buttress:Strongly disagree |
|
| Surgical staff experienced less frustration with SLR compared to previous buttress:Slightly disagree |
|
| Surgical staff experienced less frustration with SLR compared to previous buttress: Neutral |
|
| Surgical staff experienced less frustration with SLR compared to previous buttress: Slightly agree |
|
| Surgical staff experienced less frustration with SLR compared to previous buttress: Strongly agree |
|
| Foresee less waste of SLR compared to the previous buttress: Strongly disagree |
|
| Foresee less waste of SLR compared to the previous buttress: Slightly disagree |
|
| Foresee less waste of SLR compared to the previous buttress: Neutral |
|
| Foresee less waste of SLR compared to the previous buttress: Slightly agree |
|
| Foresee less waste of SLR compared to the previous buttress: Strongly agree |
|
| Likely to recommend to a colleague: Strongly disagree |
|
| Likely to recommend to a colleague: Slightly disagree |
|
| Likely to recommend to a colleague: Neutral |
|
| Likely to recommend to a colleague: Slightly agree |
|
| Likely to recommend to a colleague: Strongly agree |
|
| Satisfaction of operative flow compared to previous device: Neither dissatisfied nor satisfied |
|
| Satisfaction of operative flow compared to previous device: Satisfied |
|
| Satisfaction of operative flow compared to previous device: Very satisfied |
|
| Satisfaction of manipulation and repositioning compared to previous device:Very dissatisfied |
|
| Satisfaction of manipulation and repositioning compared to previous device: Dissatisfied |
|
| Satisfaction of manipulation and repositioning compared to previous device: NDNS |
|
| Satisfaction of manipulation and repositioning compared to previous device: Satisfied |
|
| Satisfaction of manipulation and repositioning compared to previous device: Very satisfied |
|