NCT00495222

Endoscopic Suturing System for Tissue Apposition

Evaluation of an Endoscopic Suturing System for Tissue Apposition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-04-01
• Completion: 2008-06-01
• First posted: 2007-07-03
• Last updated: 2009-09-10
• Results posted: 2009-08-11

Locations

1 site across 1 country: United States