Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT00962650
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;
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00962650
Study Brief:
Protocol Section:
NCT00962650