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

Primary Purpose

Gallbladder Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOTES GEN 1 Toolbox
Sponsored by
Ethicon Endo-Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder Disease focused on measuring gallbladder disease, cholecystectomy, gallbladder disease indicated for cholecystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cholecystectomy

Arm Description

transvaginal cholecystectomy

Outcomes

Primary Outcome Measures

Procedure Completion
Completion of procedure - transvaginal removal of the gallbladder

Secondary Outcome Measures

Full Information

First Posted
April 28, 2009
Last Updated
November 1, 2011
Sponsor
Ethicon Endo-Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT00889928
Brief Title
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
Acronym
NOTES
Official Title
A Trial to Evaluate Natural Orifice Transvaginal Endoscopic Cholecystectomy With Laparoscopic Assistance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon Endo-Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Disease
Keywords
gallbladder disease, cholecystectomy, gallbladder disease indicated for cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cholecystectomy
Arm Type
Experimental
Arm Description
transvaginal cholecystectomy
Intervention Type
Device
Intervention Name(s)
NOTES GEN 1 Toolbox
Intervention Description
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 Measure Information:
Title
Procedure Completion
Description
Completion of procedure - transvaginal removal of the gallbladder
Time Frame
Day of Surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Women will be enrolled in this study who: Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires; At least 18 years of age; Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy; ASA Classification I or II (Appendix II); Have a negative serum pregnancy test (for women of childbearing potential); and 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: BMI > 35; Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable); Suspicion of gallbladder cancer, tumor, polyps, or mass; Acute cholecystitis or acute pancreatitis; Presence of common bile duct stones; History of cervical or vaginal cancer (or precancerous findings on most recent Pap Test); Pelvic Inflammatory Disease; Evidence of abdominal abscess or mass; Diffuse peritonitis; 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; Clinical diagnosis of sepsis; History of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis; History of peritoneal or vaginal trauma; 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; Planned concurrent surgical procedure; Prior or planned major surgical procedure within 30 days before or after study procedure; History of transvaginal surgery; History of (or symptomatic for) abdominal adhesions; 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; Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; Any contraindication listed in a study device Instructions for Use (IFU) document (if that device may be used in the study procedure); or Any condition which precludes compliance with the study (Investigator discretion).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Hungness, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine - ATTN: Dr Hungness
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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