Trials / Completed
CompletedNCT02922205
Stapler Post-market Observational Study
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Duomed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endoscopic Linear Cutter Stapler and reloads | Endoscopic Linear Cutter Stapler and reloads |
Timeline
- Start date
- 2017-04-06
- Primary completion
- 2020-09-16
- Completion
- 2020-09-16
- First posted
- 2016-10-04
- Last updated
- 2020-11-06
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02922205. Inclusion in this directory is not an endorsement.