Trials / Withdrawn
WithdrawnNCT04712526
Endostapler Gastric Bypass Study
Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Lexington Medical Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.
Detailed description
Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AEON Endostapler | Surgery with AEON Endostapler |
Timeline
- Start date
- 2021-01-18
- Primary completion
- 2023-11-01
- Completion
- 2023-12-01
- First posted
- 2021-01-15
- Last updated
- 2023-10-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04712526. Inclusion in this directory is not an endorsement.