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

Ethicon Endo-Surgery1 site in 1 countrySeptember 2009

ConditionsCholecystectomy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cholecystectomy
Sponsor: Ethicon Endo-Surgery
Locations: 1
Primary Endpoint: Proportion of procedures completed
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

October 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ethicon Endo-Surgery

Responsible Party

Sponsor

Eligibility Criteria

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;