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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00962650
First received: August 12, 2009
Last updated: March 1, 2012
Last verified: March 2012

August 12, 2009
March 1, 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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00962650 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00962650
CI-08-0007
No
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