Prospective Multicenter Human Randomized Controlled Evaluation of NOTES® Cholecystectomy

Conditions

Gall Bladder Diseases

What is the purpose of this trial?

This study is designed to be a United States multicenter prospective randomized controlled non-inferiority evaluation of transgastric and transvaginal Natural Orifice Translumenal Endoscopic Surgery (NOTES) cholecystectomy compared to laparoscopic cholecystectomy in elective surgery patients. Up to 200 patients will be enrolled to obtain 70 NOTES cholecystectomies (35 transgastric and 35 transvaginal) and 70 laparoscopic cholecystectomies on a randomized basis. In order to evaluate the hypothesis that NOTES cholecystectomy has equivalent safety and efficacy to laparoscopic cholecystectomy, clinical and administrative outcomes will be measured.



Participation Guidelines

Age:
18 Years - 75 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
American Society for Gastrointestinal Endoscopy
Natural Orifice Surgery Consortium for Assessment and Research
Dates:
July 2010
Last Updated:
November 30, 2011
Study HIC#:

Clinicaltrials.gov ID: NCT01171027