Status:
WITHDRAWN
A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Cholecystectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00979186
Start Date
September 1 2009
End Date
October 1 2010
Last Update
November 29 2011
Active Locations (1)
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1
Department of Surgery, UCSD
San Diego, California, United States, 92037