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Endoscopic Suturing System for Tissue Apposition

NCT00495222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2009-09-10

Study results available
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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.

Conditions

Interventions

PROCEDURE

Tissue plication

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

DEVICE

Endoscopic Suturing System

Tissue plication of dilated GJ stoma

DEVICE

Tissue Plication

Tissue plication for GJ stoma reduction

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Alfonso Torquati, MD · Vanderbilt University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-04-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495222 on ClinicalTrials.gov