A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance

Not Applicable

Completed

• Conditions: Gallbladder Disease
• Interventions: Device: NOTES GEN 1 Toolbox

• Registration Number: NCT00889928
• Lead Sponsor: Ethicon Endo-Surgery

Brief Summary

The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2010-11
• Study Completion: 2011-08
• Status Verified: 2011-11
• Results First Submitted: 2011-11-01
• Results First Submitted QC: 2011-11-01
• Last Update Submitted: 2011-11-01
• Results First Posted: 2011-11-24
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cholecystectomy	NOTES GEN 1 Toolbox	transvaginal cholecystectomy

Primary Outcome Measures

Name	Time	Method
Procedure Completion	Day of Surgery	Completion of procedure - transvaginal removal of the gallbladder

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness; 🇺🇸 Chicago, Illinois, United States