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

Gallbladder Disease Clinical Trial

— NOTES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889928
• Other study ID #: CI-08-0004
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: November 1, 2011
• Start date: April 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00821704

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gallbladder Disease
• Gallbladder Diseases

Intervention

Device:
• NOTES GEN 1 Toolbox
Articulating Hook Knife Articulating Snare Articulating Needle Knife Articulating Graspers Articulating Biopsy Forceps Steerable Flex Trocar with Rotary Access Needle Flexible Bipolar Hemostasis Forceps Flexible Maryland Dissector

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Completion	Completion of procedure - transvaginal removal of the gallbladder	Day of Surgery	No