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

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: Gallbladder Disease
• Intervention / Treatment: Device: NOTES GEN 1 Toolbox

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Completion of procedure - transvaginal removal of the gallbladder	Day of Surgery

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Principal Investigator: Eric Hungness, MD, Northwestern University Feinberg School of Medicine

Study record dates

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: cholecystectomy; gallbladder disease; gallbladder disease indicated for cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases
• Other Study ID Numbers: CI-08-0004