A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.

Ethicon Endo-Surgery1 site in 1 country7 target enrollmentJune 2009

ConditionsAbdominal Adhesions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Abdominal Adhesions
Sponsor: Ethicon Endo-Surgery
Enrollment: 7
Locations: 1
Primary Endpoint: Completion of Diagnostic Peritineoscopy
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

October 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ethicon Endo-Surgery

Responsible Party

Sponsor

Eligibility 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;

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.