Trials / Completed
CompletedNCT04086433
Gastric Tissue Stapler Comparison Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 36 (actual)
- Sponsor
- Standard Bariatrics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- —
Summary
This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan"). The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | gastric tissue resection | human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment |
Timeline
- Start date
- 2019-07-15
- Primary completion
- 2019-10-30
- Completion
- 2019-10-30
- First posted
- 2019-09-11
- Last updated
- 2020-06-25
- Results posted
- 2020-06-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04086433. Inclusion in this directory is not an endorsement.