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

NCT ID: NCT00889928

Last Updated: 2011-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-08-31

Brief 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.

Conditions

Gallbladder Disease

Keywords

gallbladder disease; cholecystectomy; gallbladder disease indicated for cholecystectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cholecystectomy

transvaginal cholecystectomy

Group Type: EXPERIMENTAL

NOTES GEN 1 Toolbox

Intervention Type: DEVICE

• 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

Interventions

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hungness, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CI-08-0004

Identifier Type: -

Identifier Source: org_study_id

NCT00821704

Identifier Type: -

Identifier Source: nct_alias