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.
This is a single-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a D-I diversion in participants undergoing primary sleeve gastrectomy (SNAP-S cohort) or who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL at least 18 months post sleeve gastrectomy. Five patients will be enrolled in each cohort. Adult male and female subjects between the ages of 22 and 65 years-old who are candidates for the primary or revisional surgery will be considered for participation. Patients appearing to meet basic eligibility criteria and who sign the study specific consent form will be screened for enrollment into this study and will be assessed by a multidisciplinary research team with pre-procedure nutritional and medical evaluation (including psychological and behavioral evaluation by an internist/bariatrician). Subjects meeting the inclusion and exclusion criteria and enrolled into the study will undergo a dual-path enteral diversion using the SFM anastomosis device in which the duodenum will be connected to the ileum with the creation of a side-by-side anastomosis using the SFM device and delivery systems. For subjects undergoing concurrent sleeve gastrectomy and D-I Diversion (SNAP-S cohort) it is anticipated that the D-I diversion will be created first followed by the sleeve gastrectomy (unless the investigator determines that the reverse order is more appropriate for a particular subject).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
To create the duodenal-ileal diversion, the duodenal magnet will be placed transorally in the proximal duodenum and the distal magnet will be placed in the ileum. Magnets are coupled and a compression induced anastomosis is created.
Bariatric Medicine Institute
Salt Lake City, Utah, United States
Weight Loss
Total Body Weight Loss from baseline
Time frame: 12 months
Percent Responders
Percent of patients losing at least 10% of their baseline weight
Time frame: 12 Months
%EWL
Mean Excess Weight Loss from baseline
Time frame: 12 Months
Serum lipids
Mean change of serum lipids from baseline
Time frame: 12 Months
Systolic/diastolic blood pressure
Mean percent change in systolic/diastolic blood pressure from baseline
Time frame: 12 Months
Hemoglobin A1c
Mean change of hemoglobin A1c (in patients with Type 2 Diabetes (T2DM) from baseline
Time frame: 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
NONE
Enrollment
10