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
21–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Subjects must fulfill the following criteria to be entered in this study:
Review and sign informed consent;
Between 21 and 65 years of age (inclusive) at time of trial enrollment;
Documented Roux-en-Y Gastric Bypass (RYGB) surgery date
Documented baseline weight at the time of RYGB procedure;
\> 12 months post RYGB);
Body mass Index (BMI) \> 30 and at least 20 pounds in excess of post-RYGB weight nadir;
Patients initially achieved at least 50% excess weight loss (EWL) post RYGB;
Visible anastomotic junction (between gastric pouch and the Roux-limb);
Stoma size at screening \> 15mm; and
Negative serum pregnancy test for women of childbearing potential.
You may not be if
Subjects will be excluded from the trial for any of the following:
Documented history of esophageal pathology (e.g., esophageal varices, Barrett's Esophagus);
American Anesthesia Association (ASA) Class IV or V and/or any contraindications to monitored anesthesia;
Documented history of GJ anastomosis stricture (within 6 months);
Documented history of previous RYGB revision;
Presence or documented presence of gastric/duodenal ulcers;
Presence of sepsis;
Medical or physical endoscopic contraindications, including esophageal varices or bleeding, laryngeal perforation, trauma to pharynx, aspiration pneumonia, acute peritonitis, and other conditions where general endoscopic techniques and/or placement of overtube are contraindicated;
Chronic Non-Steroidal Anti-Inflammatory Drug (NSAID) use (subjects taking a single aspirin tablet per day for cardioprotection are considered acceptable);
Uncontrolled diabetes;
Physical or psychological condition which would impair trial participation per investigator discretion;
Binge-eating or similar eating disorders;
Unable or unwilling to attend follow-up visits and examinations;
Concurrent surgical procedure (intra-operative exclusion during ESS procedure);
Participation in any other investigational device or drug trial within 30 days prior to enrollment; or
Any condition, which precludes compliance with the trial.
