Endoscopic Suturing System for Tissue Apposition

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT00495222
• Lead Sponsor: Ethicon Endo-Surgery

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-06-29
• Study First Submitted QC: 2007-07-02
• Study First Posted: 2007-07-03
• Primary Completion: 2008-04
• Study Completion: 2008-06
• Results First Submitted: 2009-04-21
• Results First Submitted QC: 2009-08-10
• Results First Posted: 2009-08-11
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-08
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Knotting Elements Placed	intra-operative	completion of plication (1-3 knotting elements placed per procedure)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States