N/A
N=35
Gastric Tissue Stapler Comparison Study
Gastric Resection
Bottom Line
View on ClinicalTrials.gov: NCT04086433 ↗Enrolled (actual)
35
Serious AEs
—
Results posted
Jun 2020
Primary outcome: Primary: Pressure Evaluation — 126; 163 mmHg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- gastric tissue resection (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Standard Bariatrics
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pressure Evaluation |
126; 163 | — |
| PRIMARY Staple Malformation |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80
Exclusion Criteria
- Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
- Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
- Stomach damaged during extraction
Data sourced from ClinicalTrials.gov (NCT04086433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.