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

November 1, 2011 updated by: Ethicon Endo-Surgery
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Completion
Time Frame: Day of Surgery
Completion of procedure - transvaginal removal of the gallbladder
Day of Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery

Investigators

  • Principal Investigator: Eric Hungness, MD, Northwestern University Feinberg School Of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (ESTIMATE)

April 29, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 24, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-08-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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