Evaluate the Initial Safety and Device Functionality of the SFM Anastomosis Device for a Primary Sleeve Gastrectomy Duodenal-Ileal Anastomosis (SNAP-S) or After Primary Sleeve Gastrectomy (SNAP-PS) or to Create a Jejuno-Jejunostomy in a Roux-en-Y Gastric Bypass (J-J)
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 duodenal-ileal (D-I) anastomosis 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) or a Roux-en-Y gastric bypass jejuno-jejunostomy. Additionally, the study is designed to evaluate the potential of these procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.
• All Subjects:
‣ Age 18-65 years at screening
⁃ For the primary or post sleeve gastrectomy Anastomosis procedures (SNAP-S/SNAP-PS)- Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 but ≤ 55 kg/m2 at time of screening 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
⁃ For the Roux-en-Y gastric bypass jejuno-jejunostomy procedure (J-J) - Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 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 150-km radius of study center for 12 months
⁃ Willing to commit to sustained healthy behaviors that include diet, eating and exercise habits for the duration of the trial
⁃ Willing to refrain from smoking during the study follow-up period
⁃ If subject is female, she must commit to not becoming pregnant for 12 months and agree to use of contraceptives during this period and may not be nursing