Trials / Withdrawn
WithdrawnNCT04543526
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
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Duomed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) | Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2024-10-31
- Completion
- 2024-11-30
- First posted
- 2020-09-10
- Last updated
- 2022-01-11
Locations
2 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04543526. Inclusion in this directory is not an endorsement.