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

Ethicon

Status

Completed

Conditions

Abdominal Adhesions

Treatments

Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance

Study type

Interventional

Funder types

Industry

Identifiers

NCT00962650

CI-08-0007

Details and patient eligibility

About

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

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).