CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
gastric tissue resectiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04086433
NCT04086433N/ACompleted
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Gastric Tissue Stapler Comparison Study

Standard Bariatrics·observational·Posted Sep 11, 2019·Updated Jun 25, 2020

In Brief

An observational study evaluating gastric tissue resection for Gastric Resection. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Resection
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 11, 2019
Enrollment StartJul 15, 2019
Primary CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.8 years ago

Interventions

gastric tissue resectiondevice

human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment