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
  Purpose

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


Condition Intervention
Abdominal Adhesions
Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • 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.



Enrollment: 7
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NOTES Toolbox
Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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;
  • 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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962650

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Jeffrey W Hazey, MD, FACS Ohio State University
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00962650     History of Changes
Other Study ID Numbers: CI-08-0007
Study First Received: August 12, 2009
Results First Received: December 20, 2010
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:
abdominal adhesions
diagnostic peritoneoscopy
Natural Orifice Transluminal Endoscopic Surgery
NOTES

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014