Withdrawn before it began
A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
NCT04543526 · Duomed · Updated 11 Jan 2022
- What is being tested
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- For
- Obesity; Roux-en-Y Gastric Bypass
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. The full rules are on the registry page.
- Where
- Belgium (2 sites)
- When
- Starts or started 1 Sept 2021, ends 30 Nov 2024. Registered 10 Sept 2020.
- Results
- None posted yet.
In the researchers' words
The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.
Sites
- Ziekenhuis Oost-Limburg (ZOL)Genk, Belgium
- Ziekenhuis Maas en Kempen (ZMK)Maaseik, Belgium