A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
Withdrawn before enrolling · Not applicable
Conditions studied: Cholecystectomy
In brief
The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.
Key facts
- Study ID
- NCT00979186
- Run by
- Ethicon Endo-Surgery
- People needed
- 0
- Starts
- 2009-09-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2011-11-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Department of Surgery, UCSD — San Diego, California, United States
Full record on ClinicalTrials.gov
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