Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance (NOTES)

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. Identifier: NCT00962650
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Information provided by (Responsible Party):
Ethicon Endo-Surgery

August 12, 2009
August 20, 2009
December 20, 2010
March 29, 2012
March 29, 2012
June 2009
October 2010   (Final data collection date for primary outcome measure)
Completion of Diagnostic Peritineoscopy [ Time Frame: Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar ]

Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox

Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome.

Completion of procedure [ Time Frame: End of procedure or surgery (1 day) ]
Complete list of historical versions of study NCT00962650 on Archive Site
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Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance
A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.
The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.
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Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Abdominal Adhesions
Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance
Device: Natural Orifice Transgastric Endoscopic (NOTES GEN 1 Toolbox): Articulating Hook Knife(IN2505), Articulating Snare (IN2503), Articulating Needle Knife(IN2504), Articulating Graspers(IN2501 or IN2506), Articulating Biopsy Forceps(IN2502), Steerable Flexible Trocar (IN0501) with Rotary Access Needle (IN0502), Flexible Bipolar Hemostasis Forceps (IN0301), and/or Flexible Maryland Dissector(IN1601)
Experimental: NOTES Toolbox
Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial
Intervention: Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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;
  • At least 18 years of age;
  • Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site;
  • Have a history of open abdominal surgery or laparoscopic abdominal surgery;
  • ASA Classification I, II, or III (Appendix II); and
  • Have a negative serum pregnancy test (for women of childbearing potential).

Exclusion Criteria:

Subjects will be excluded from the study for any of the following:

  • Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
  • Acute cholecystitis or acute pancreatitis;
  • 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;
  • 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 other than RYGB or adhesiolysis;
  • Prior or planned major surgical procedure within 30 days before or after study procedure;
  • 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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Ethicon Endo-Surgery
Ethicon Endo-Surgery
Not Provided
Principal Investigator: Jeffrey W Hazey, MD, FACS Ohio State University
Ethicon Endo-Surgery
March 2012

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