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

The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.

Study Overview

• Status: Withdrawn
• Conditions: Cholecystectomy
• Intervention / Treatment: Device: NOTES GEN 1 Toolbox

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Department of Surgery, UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Men and 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); and
• Have a negative serum pregnancy test (for women of childbearing potential);
• Have the study procedure attempted.

Exclusion Criteria:

• 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 open abdominal surgery;
• 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 peritoneal 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;
• Previous diagnosis of intra-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; or
• Any condition which precludes compliance with the study (Investigator discretion).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of procedures completed	Day of surgery only - study complete at end of prodecure.	1 Day

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 16, 2009
• First Submitted That Met QC Criteria: September 16, 2009
• First Posted (Estimate): September 17, 2009

Study Record Updates

• Last Update Posted (Estimate): November 29, 2011
• Last Update Submitted That Met QC Criteria: November 28, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: transgastric cholecystectomy
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: CI-08-0005