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

Ethicon

Status: Completed

Conditions: Gallbladder Disease

Treatments: Device: NOTES GEN 1 Toolbox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889928

CI-08-0004

Details and patient eligibility

About

The study will document being able to successfully remove a subject's gallbladder through the vagina (laparoscopic visualization)using a small collection of study surgical tools.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

cholecystectomy

Experimental group

Description:

transvaginal cholecystectomy

Treatment:

Device: NOTES GEN 1 Toolbox