Trials / Completed
CompletedNCT02358785
Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Ethicon Endo-Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ECHELON FLEX™ Powered Plus Stapler | ECHELON FLEX™ Powered Plus Stapler using ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEX™ GST System. |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2015-10-01
- Completion
- 2015-11-01
- First posted
- 2015-02-09
- Last updated
- 2017-08-11
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02358785. Inclusion in this directory is not an endorsement.