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

This study has been withdrawn prior to enrollment.
(Study Terminated - No enrollment, business decision.)
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00979186
First received: September 16, 2009
Last updated: November 28, 2011
Last verified: December 2010
  Purpose

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


Condition Intervention
Cholecystectomy
Device: NOTES GEN 1 Toolbox

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Proportion of procedures completed [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    Day of surgery only - study complete at end of prodecure.


Enrollment: 0
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979186

Locations
United States, California
Department of Surgery, UCSD
San Diego, California, United States, 92037
Sponsors and Collaborators
Ethicon Endo-Surgery
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00979186     History of Changes
Other Study ID Numbers: CI-08-0005
Study First Received: September 16, 2009
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:
transgastric cholecystectomy

Additional relevant MeSH terms:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014