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This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 1100 Shears and Generator G11 instructions for use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic) | Experimental | Any pediatric or adult (hepato-pancreato-biliary, lower gastrointestinal, gastric, gynecological, urological, thoracic) procedures where the HARMONIC 1100 Shears is used for vessel transection according to instructions for use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HARMONIC 1100 Shears | Device | HARMONIC 1100 Shears is used for vessel transection according to instructions for use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | Number of vessels transected with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | On the day of transection (Day 0) |
| Number of Participants With Device-related Adverse Events (AEs) | Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study device. Possible refers to the relationship with the use of the device is weak but cannot be ruled out completely; Probable refers to the relationship with the use of the device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be obtained; Causal relationship refers to the event is associated with the device or with procedures beyond reasonable doubt. | From Day 0 up to post-procedure follow up visit (up to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | Number of vessels transected with diameter >5 to 7 mm with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). |
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Inclusion Criteria:
Pediatric population:
Adult population:
Exclusion Criteria:
Preoperative
Intraoperative
1. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Ethicon Endo-Surgery Clinical Trial | Ethicon Endo-Surgery | Study Director |
| Troy Markel, MD | Riley Hospital for Children at Indiana University Health | Principal Investigator |
| Attila Nakeeb, MD | IU Health University Hospital | Principal Investigator |
| Moishe Liberman, MD | Centre Hospitalier de l'Universite de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health | Jacksonville | Florida | 32207 | United States | ||
| Indiana University |
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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| ID | Title | Description |
|---|---|---|
| FG000 | HARMONIC 1100 Shears | HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | May 17, 2023 | Jan 27, 2025 |
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| On the day of transection (Day 0) |
| Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score | Number of participants using HARMONIC 1100 Shears for sealing and transection of lymphatic vessels as assessed by Surgeon Satisfaction Scale Score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for sealing and transection of lymphatic vessel by HARMONIC 1100 Shears. | On the day of transection (Day 0) |
| Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Number of vessels transected with hemostasis (Grade 1 to 4) based on hemostasis grading scale was reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | On the day of transection (Day 0) |
| Number of Grade 4 Vessel Transections Requiring Hemostasis Measures | Number of Grade 4 vessel transections requiring hemostasis measures such as hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products and other products were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products). Since multiple responses were collected, sum of the data of each category exceeds the overall number of units analyzed. | On the day of transection (Day 0) |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Canada |
| Toronto General Hospital | Toronto | Canada |
| Western General Hospital | Edinburgh | Scotland | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HARMONIC 1100 Shears | HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | Number of vessels transected with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, "Overall number of units analyzed" signifies total number of vessels transected and analyzed for this outcome measure. | Posted | Count of Units | Vessels transected | On the day of transection (Day 0) | Vessels transected | Vessels transected |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Device-related Adverse Events (AEs) | Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study device. Possible refers to the relationship with the use of the device is weak but cannot be ruled out completely; Probable refers to the relationship with the use of the device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be obtained; Causal relationship refers to the event is associated with the device or with procedures beyond reasonable doubt. | Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. | Posted | Count of Participants | Participants | From Day 0 up to post-procedure follow up visit (up to 28 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | Number of vessels transected with diameter >5 to 7 mm with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, "Overall number of units analyzed" signifies total number of vessels transected and analyzed for this outcome measure. | Posted | Count of Units | Vessels transected | On the day of transection (Day 0) | Vessels transected | Vessels transected |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score | Number of participants using HARMONIC 1100 Shears for sealing and transection of lymphatic vessels as assessed by Surgeon Satisfaction Scale Score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for sealing and transection of lymphatic vessel by HARMONIC 1100 Shears. | Analysis population included participants in FAS with sealing and transection of lymphatic vessels by HARMONIC 1100 Shears. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Number of vessels transected with hemostasis (Grade 1 to 4) based on hemostasis grading scale was reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, "Overall number of units analyzed" signifies total number of vessels transected and analyzed for this outcome measure. | Posted | Count of Units | Vessels transected | On the day of transection (Day 0) | Vessels transected | Vessels transected |
| ||||||||||||||||||||||||||||
| Secondary | Number of Grade 4 Vessel Transections Requiring Hemostasis Measures | Number of Grade 4 vessel transections requiring hemostasis measures such as hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products and other products were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products). Since multiple responses were collected, sum of the data of each category exceeds the overall number of units analyzed. | Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, "Overall number of units analyzed" signifies Grade 4 vessels transections. | Posted | Count of Units | Vessels transected | On the day of transection (Day 0) | Vessels transected | Vessels transected |
|
From Day 0 up to post-procedure follow up visit (Up to 28 days)
Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.
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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 | HARMONIC 1100 Shears | HARMONIC 1100 Shears was used per the Instructions for use (IFUs) in pediatric surgical procedures (general) or adult surgical procedures (general, gynecological, urological, and thoracic) where at least one single vessel was transected. | 1 | 265 | 16 | 265 | 69 | 265 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Post procedural pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Postoperative respiratory failure | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Anastomotic haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Confusion postoperative | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Incision site pruritus | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Incision site vesicles | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Penis injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Splenic injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Aspiration pleural cavity | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Bladder discomfort | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 23.0 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Medical Affair-Endomechanical and Trx | Ethicon Endo-Surgery, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2023 | Jan 27, 2025 | SAP_001.pdf |
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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| Vessels transected |
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| Units |
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| Counts |
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| Participants |
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| Vessels transected |
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