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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 16, 2009
Last Updated Date	November 28, 2011
Start Date ^ICMJE	September 2009
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 27, 2010)	Proportion of procedures completed [ Time Frame: 1 Day ] [ Designated as safety issue: No ] Day of surgery only - study complete at end of prodecure.
Original Primary Outcome Measures ^ICMJE (submitted: September 16, 2009)	Proportion of procedures completed [ Time Frame: 1 Day (At surgery completion) ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00979186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
Official Title ^ICMJE	A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
Brief Summary	The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cholecystectomy
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00979186
Other Study ID Numbers ^ICMJE	CI-08-0005
Has Data Monitoring Committee	No
Responsible Party	Ethicon Endo-Surgery
Study Sponsor ^ICMJE	Ethicon Endo-Surgery
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ethicon Endo-Surgery
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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