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

Exclusion Criteria

• •Subjects will be excluded from the study for any of the following:
• •1. BMI \> 35;
• •2. Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
• •3. Suspicion of gallbladder cancer, tumor, polyps, or mass;
• •4. Acute cholecystitis or acute pancreatitis;
• •5. Presence of common bile duct stones;
• •6. History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test);
• •7. Pelvic Inflammatory Disease;
• •8. Evidence of abdominal abscess or mass;
• •9. Diffuse peritonitis;
• •10. 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;
• •11. Clinical diagnosis of sepsis;
• •12. History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis;
• •13. History of peritoneal or vaginal trauma;
• •14. 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;
• •15. Planned concurrent surgical procedure;
• •16. Prior or planned major surgical procedure within 30 days before or after study procedure;
• •17. History of transvaginal surgery;
• •18. History of (or symptomatic for) abdominal adhesions;
• •19. 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;
• •20. Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox;
• •21. Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or
• •22. Any condition which precludes compliance with the study (Investigator discretion).