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

NCT00979186 | Withdrawn

• 1 other identifier: CI-08-0005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of procedures completed

  Day of surgery only - study complete at end of prodecure.

  1 Day

Interventions

NOTES GEN 1 Toolbox DEVICE

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.

Also known as: 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

Department of Surgery, UCSD

San Diego, California, 92037, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 29, 2011

Record last verified: 2010-12

Locations

US (1)