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

Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00979186
• Other study ID #: CI-08-0005
• Status: Withdrawn
• Phase: N/A
• First received: September 16, 2009
• Last updated: November 28, 2011
• Start date: September 2009
• Est. completion date: October 2010

Study information

• Verified date: December 2010
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystectomy

Intervention

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, and Tissue Apposition System.

Locations

Country	Name	City	State
United States	Department of Surgery, UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of procedures completed	Day of surgery only - study complete at end of prodecure.	1 Day	No