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

Inclusion criteria

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);
• Have a negative serum pregnancy test (for women of childbearing potential); and
• Absence, on visual inspection, of adhesions judged to be a potentially complicating factor in transvaginal access and operation.

Exclusion criteria

Subjects will be excluded from the study for any of the following:

• 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 cervical or vaginal cancer (or precancerous findings on most recent Pap Test);
• Pelvic Inflammatory Disease;
• 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 ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis;
• History of peritoneal or vaginal 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;
• History of transvaginal surgery;
• History of (or symptomatic for) 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;
• Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or
• Any condition which precludes compliance with the study (Investigator discretion).