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

Not Applicable

Withdrawn

• Conditions: Cholecystectomy

• Registration Number: NCT00979186
• Lead Sponsor: Ethicon Endo-Surgery

Brief Summary

The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-12
• Last Update Submitted: 2011-11-28
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Men and women will be enrolled in this study who:

• Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
• At least 18 years of age;
• Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
• ASA Classification I or II (Appendix II); and
• Have a negative serum pregnancy test (for women of childbearing potential);
• Have the study procedure attempted.

Exclusion Criteria

• BMI > 35;
• Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
• Suspicion of gallbladder cancer, tumor, polyps, or mass;
• Acute cholecystitis or acute pancreatitis;
• Presence of common bile duct stones;
• History of open abdominal surgery;
• Evidence of abdominal abscess or mass;
• Diffuse peritonitis;
• Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
• Clinical diagnosis of sepsis;
• History of peritoneal trauma;
• Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
• Planned concurrent surgical procedure;
• Prior or planned major surgical procedure within 30 days before or after study procedure;
• Previous diagnosis of intra-abdominal adhesions;
• Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
• Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or
• Any condition which precludes compliance with the study (Investigator discretion).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of procedures completed	1 Day	Day of surgery only - study complete at end of prodecure.

Trial Locations

Locations (1)

Department of Surgery, UCSD; 🇺🇸 San Diego, California, United States