sleeve gastrectomy or gastric bypass
Conditions
Interventions
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. The subject must be 18-80 years of age 2. The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent 3. The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA* Reload with Tri-Staple* Technology device will be used per its Instructions For Use -For Thoracic procedures, these may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures (not in The Netherlands) -For Abdominal procedures, these 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 4. For thoracic subjects: the subject has a FEV1 *40% (Not in The Netherlands)
Exclusion criteria
Exclusion criteria: Subjects undergoing cardiac and vascular procedures 2. The procedure is an emergency procedure 3. The procedure is a revision/reoperation for the same indication 4. Any female subject who is pregnant. 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) 6. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity) 7. The subject is unable or unwilling to comply with the study requirements or follow-up schedule 8. 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 9. The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment. 10. The subject is concurrently enrolled in another investigational drug or device research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the incidence of reported device-related adverse events (AEs) at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures assessed will include > the Staple line assessment: - Intraoperative assessments: Incidence of staple line bleeding (measured as * 50 cc) - Incidence of leakage (as measured by air leak test, or standard of care, as applicable) - Post-operative assessments: * Duration of leakage (in days) for thoracic procedures * Incidence of leakage for abdominal procedures * Incidence of post-operative infection * Additional intervention(s) to treat staple-line failure > Incidence of repeat hospital admissions for procedural-related complications | — |
Countries
Austria, Belgium, France, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed