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

NCT ID: NCT00979186

Last Updated: 2011-11-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-10-31

Brief Summary

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

Conditions

Cholecystectomy

Keywords

transgastric cholecystectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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, and Tissue Apposition System.

Intervention Type: DEVICE

Other Intervention Names

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, and Tissue Apposition System.

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Surgery, UCSD

San Diego, California, United States

Countries

United States

Other Identifiers

CI-08-0005

Identifier Type: -

Identifier Source: org_study_id