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A post-market study of the Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology.
The objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology in subjects undergoing indicated abdominal or thoracic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal Procedures | Experimental | Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection. Device: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology |
|
| Thoracic Procedures | Experimental | Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures. Device: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology | Device | Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. | Through 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Staple Line Assessment: Incidence of Staple Line Bleeding | The incidence of staple line bleeding will be measured as ≥ 50 cc | Day 0 |
| Staple Line Assessment: Incidence of Leakage | As measured by air leak test, or standard of care, as applicable |
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Inclusion Criteria:
The subject must be 18-80 years of age
The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) will be used per its Instructions For Use (IFU)
For thoracic subjects: the subject has a FEV1 ≥40%
Exclusion Criteria:
Subjects undergoing cardiac and vascular procedures
The procedure is an emergency procedure
The procedure is a revision/reoperation for the same indication
Any female subject who is pregnant
a. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test (except for subjects who are surgically sterile or are post-menopausal for at least two years)
Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
The subject is unable or unwilling to comply with the study requirements or follow-up schedule
The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment
The subject is concurrently enrolled in an investigational drug or device research study
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Ahmed, PhD, FRCS | St Mary's Hospital, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mary's Hospital | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abdominal Procedures | Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) |
| FG001 | Thoracic Procedures | Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abdominal Procedures | Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) |
| 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 | The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures. | Posted | Number | Device related adverse events | Through 30 Days |
|
30 days
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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 | Abdominal Procedures | Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle DiSalvo | Medtronic | 774.284.6089 | michelle.v.disalvo@medtronic.com |
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| Day 0 |
| Staple Line Assessment: Duration of Leakage, Post-Op | Duration of leakage based on chest tube drainage in days | Participants will be followed for the duration of hospital stay, on average up to 5 days |
| Staple Line Assessment: Incidence of Leakage; Post-Op | The incidence of leakage for abdominal procedures; Post-up | Participants will be followed for the duration of hospital stay, on average up to 5 days |
| Staple Line Assessment: Incidence of Post-operative Infection | Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients | Participants will be followed for the duration of hospital stay, on average up to 5 days |
| Staple Line Assessment: | Number of additional intervention(s) to treat staple-line failure | Participants will be followed for the duration of hospital stay, on average up to 5 days post-op |
| Incidence of Repeat Hospital Admissions for Procedural-related Complications | Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure | 30 Days following procedure |
| Withdrawal by Subject |
|
| BG001 | Thoracic Procedures | Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| FEV1 Score (thoracic) | FEV1 Score is captured for the thoracic population | Mean | Standard Deviation | percent |
|
|
|
| Secondary | Staple Line Assessment: Incidence of Staple Line Bleeding | The incidence of staple line bleeding will be measured as ≥ 50 cc | Posted | Number | incidences of staple line bleeding | Day 0 |
|
|
|
| Secondary | Staple Line Assessment: Incidence of Leakage | As measured by air leak test, or standard of care, as applicable | Posted | Number | incidences of leakage | Day 0 |
|
|
|
| Secondary | Staple Line Assessment: Duration of Leakage, Post-Op | Duration of leakage based on chest tube drainage in days | Thoracic patients only | Posted | Mean | Standard Deviation | days | Participants will be followed for the duration of hospital stay, on average up to 5 days |
|
|
|
| Secondary | Staple Line Assessment: Incidence of Leakage; Post-Op | The incidence of leakage for abdominal procedures; Post-up | Abdominal patients only | Posted | Number | participants | Participants will be followed for the duration of hospital stay, on average up to 5 days |
|
|
|
| Secondary | Staple Line Assessment: Incidence of Post-operative Infection | Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients | Posted | Number | participants | Participants will be followed for the duration of hospital stay, on average up to 5 days |
|
|
|
| Secondary | Staple Line Assessment: | Number of additional intervention(s) to treat staple-line failure | Posted | Number | participants | Participants will be followed for the duration of hospital stay, on average up to 5 days post-op |
|
|
|
| Secondary | Incidence of Repeat Hospital Admissions for Procedural-related Complications | Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure | Posted | Number | participants | 30 Days following procedure |
|
|
|
| 2 |
| 60 |
| 12 |
| 60 |
| 14 |
| 60 |
| EG001 | Thoracic Procedures | Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology: Endo GIAâ„¢ Reinforced Reload with Tri-Stapleâ„¢ Technology (Universal Handle) | 0 | 40 | 5 | 40 | 14 | 40 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Aortic rupture | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Complication of device removal | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Hyperthermia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Anaesthetic complication | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Confusion postoperative | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Oncologic complication | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Oxygen supplementation | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
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