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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00979186
First Posted: September 17, 2009
Last Update Posted: November 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ethicon Endo-Surgery
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance

Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Proportion of procedures completed [ Time Frame: 1 Day ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979186


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

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00979186     History of Changes
Other Study ID Numbers: CI-08-0005
First Submitted: September 16, 2009
First Posted: September 17, 2009
Last Update Posted: November 29, 2011
Last Verified: December 2010

Keywords provided by Ethicon Endo-Surgery:
transgastric cholecystectomy