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

Completed · Not applicable

Conditions studied: Abdominal Adhesions

In brief

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

Key facts

Study ID

NCT00962650

Run by

Ethicon Endo-Surgery

People needed

7

Starts

2009-06-01

Expected to finish

2010-10-01

Last updated by the study team

2012-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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