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NCT04086433 · ClinicalTrials.gov registry record
Gastric Tissue Stapler Comparison Study
A clinical trial of Gastric Resection, sponsored by Standard Bariatrics.
- Completed
- Registry status
- 36
- Enrollment target
- 1
- Study location
NCT04086433: Completed study of Gastric Resection, sponsored by Standard Bariatrics.
NCT04086433 is a study of Gastric Resection that has completed, run by Standard Bariatrics. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04086433, a study of Gastric Resection, has completed, sponsored by Standard Bariatrics.
- COMPLETED
- Registry status
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
Conditions Studied
Interventions
- DEVICE gastric tissue resection
Study Locations (1)
New York
- University at Buffalo - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2019-10-30 |
What the finished NCT04086433 record still lists
NCT04086433 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target.
The record links to 1 condition, with Gastric Resection appearing as the primary indexed condition, and to 1 intervention - of which gastric tissue resection is the first listed.
NCT04086433 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04086433 about?
NCT04086433 is a clinical study titled "Gastric Tissue Stapler Comparison Study". 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 ce...
What is the current status of trial NCT04086433?
This trial is currently completed. The enrollment target is 36 participants. The study started on 2019-07-15. Estimated completion is 2019-10-30.
What conditions does trial NCT04086433 study?
This clinical trial studies the following conditions: Gastric Resection.
What interventions are being tested in trial NCT04086433?
The interventions under investigation include: gastric tissue resection (DEVICE).
Who is sponsoring clinical trial NCT04086433?
This trial is sponsored by Standard Bariatrics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04086433 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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