CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Tissue plication +2 moreprocedure
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/NCT00495222
NCT00495222N/ACompleted
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Evaluation of an Endoscopic Suturing System for Tissue Apposition

Ethicon Endo-Surgery·interventional·Posted Jul 3, 2007·Updated Sep 10, 2009

In Brief

A clinical study evaluating Tissue plication, Endoscopic Suturing System, and 1 other intervention for Obesity. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Post-procedure weight will be followed to assess whether weight loss is resumed. The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to facilitate endoscopic gastrointestinal procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 3, 2007
Enrollment StartFeb 1, 2007
Primary CompletionApr 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.0 years ago

Interventions

Tissue plicationprocedure

Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System

Endoscopic Suturing Systemdevice

Tissue plication of dilated GJ stoma

Tissue Plicationdevice

Tissue plication for GJ stoma reduction