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

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ClinicalTrials.gov Identifier: NCT00889928
Recruitment Status : Completed
First Posted : April 29, 2009
Results First Posted : November 24, 2011
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

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.

Condition or disease Intervention/treatment Phase
Gallbladder Disease Device: NOTES GEN 1 Toolbox Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
Study Start Date : April 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : August 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Procedure Completion [ Time Frame: Day of Surgery ]
    Completion of procedure - transvaginal removal of the gallbladder



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00889928     History of Changes
Obsolete Identifiers: NCT00821704
Other Study ID Numbers: CI-08-0004
First Posted: April 29, 2009    Key Record Dates
Results First Posted: November 24, 2011
Last Update Posted: November 24, 2011
Last Verified: November 2011

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