Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Device: NOTES toolbox

• Registration Number: NCT00911989
• Lead Sponsor: Ethicon Endo-Surgery

Brief Summary

The main objective of this trial is to evaluate endoscopic visualization during a laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally through a new device called a Steerable Flex Trocar (SFT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-31
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Study Start: 2009-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-10-04
• Results First Submitted QC: 2011-10-04
• Results First Posted: 2011-11-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvaginal Sleeve Gastrectomy	NOTES toolbox	Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)

Primary Outcome Measures

Name	Time	Method
Proportion of Procedures Completed With Successful Endoscopic Visualization.	Assessed intra-operatively	The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.

Trial Locations

Locations (1)

Riverside Hospital; 🇺🇸 Columbus, Ohio, United States