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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014