Trials / Completed
CompletedNCT04617574
Endostapler Sleeve Gastrectomy Study
A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (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 measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.
Detailed description
Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG 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 |
| DEVICE | Endo GIA Reloads with Tri-Staple Technology | Surgery with Endo GIA Reloads with Tri-Staple Technology |
Timeline
- Start date
- 2020-09-15
- Primary completion
- 2021-06-10
- Completion
- 2021-07-10
- First posted
- 2020-11-05
- Last updated
- 2021-10-22
- Results posted
- 2021-10-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04617574. Inclusion in this directory is not an endorsement.