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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00889928
First received: April 28, 2009
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Gallbladder Disease
Device: NOTES GEN 1 Toolbox

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Procedure Completion [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Completion of procedure - transvaginal removal of the gallbladder


Enrollment: 7
Study Start Date: April 2009
Study Completion Date: August 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cholecystectomy
transvaginal cholecystectomy
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889928

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Eric Hungness, MD Northwestern University Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00889928     History of Changes
Obsolete Identifiers: NCT00821704
Other Study ID Numbers: CI-08-0004
Study First Received: April 28, 2009
Results First Received: November 1, 2011
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:
gallbladder disease
cholecystectomy
gallbladder disease indicated for cholecystectomy

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014