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

Ethicon

Status

Withdrawn

Conditions

Cholecystectomy

Treatments

Device: NOTES GEN 1 Toolbox

Study type

Interventional

Funder types

Industry

Identifiers

NCT00979186

CI-08-0005

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).