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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gallbladder Disease

Intervention / Treatment
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* Device: NOTES GEN 1 Toolbox


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cholecystectomy<br>transvaginal cholecystectomy | Device: NOTES GEN 1 Toolbox<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gallbladder disease, cholecystectomy, gallbladder disease indicated for cholecystectomy