NCT00962650CompletedNot Applicable
A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.
Ethicon Endo-Surgery2 sites in 1 country7 target enrollmentStarted: June 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Completion of Diagnostic Peritineoscopy
Study Overview
Brief Summary
The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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