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

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

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

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).