Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Wei… (NCT05064722) | Clinical Trial Compass
CompletedNot Applicable
Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve
United States10 participantsStarted 2021-11-08
Plain-language summary
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a dual-path duodenal-ileal (D-I) diversion either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SNAP-S/SNAP-PS procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 22-65 years at screening
✓. Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 with at least one obesity related comorbidity or ≥ 40 but ≤ 50 kg/m2 with or without comorbidities at time of screening.
✓. If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
✓. Able to understand and sign informed consent document
✓. Patient lives, and intends to remain, within a 300-km radius of study center for 24 months
✓. Willing to refrain from smoking during the study follow-up period
✓. If subject is female, she must commit to not becoming pregnant for 24 months and agree to use of contraceptives during this period and may not be nursing
Exclusion criteria
✕. Type 1 Diabetes
✕. Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c \>10 or use of injectable insulin
✕. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
✕. Contraindication to general anesthesia
✕. Clinically significant finding during procedural endoscopy such as presence of an unhealed ulcers, bleeding lesions, tumors or ischemic or necrotic tissue at target magnet deployment site
✕. Congenital or acquired anomalies of the GI tract, including atresias, stenosis, prior obstruction or malrotation
✕. Presence of a duodenal diverticulum (\>10mm)
✕. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy for SNAP-PS cohort), pancreas or right colon