Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT00889928
Eligibility Criteria:
Inclusion Criteria
Women will be enrolled in this study who:
1. Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
2. At least 18 years of age;
3. Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
4. ASA Classification I or II (Appendix II);
5. Have a negative serum pregnancy test (for women of childbearing potential); and
6. 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:
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).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00889928
Study Brief:
Protocol Section:
NCT00889928