Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ethicon Endo-Surgery
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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).
