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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This study has been withdrawn prior to enrollment.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:
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

September 16, 2009
November 28, 2011
September 2009
October 2010   (final data collection date for primary outcome measure)
Proportion of procedures completed [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Day of surgery only - study complete at end of prodecure.
Proportion of procedures completed [ Time Frame: 1 Day (At surgery completion) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00979186 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cholecystectomy
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2010
October 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00979186
CI-08-0005
No
Ethicon Endo-Surgery
Ethicon Endo-Surgery
Not Provided
Not Provided
Ethicon Endo-Surgery
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP