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Endoscopic Suturing System for Tissue Apposition

2014-07-23 21:28:57 | BioPortfolio

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 Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Obesity

Intervention

Tissue plication, Endoscopic Suturing System, Tissue Plication

Location

Vanderbilt University Medical Center
Nashville
Tennessee
United States
37232

Status

Completed

Source

Ethicon Endo-Surgery

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:28:57-0400

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