Active — Not RecruitingNot Applicable

Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)

Chile, India28 participantsStarted 2023-12-15

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 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Primary Effectiveness Endpoint:

Timeframe: 30 days

Primary Safety Endpoint:

Timeframe: 30 days

Trial details

NCT IDNCT06199635

SponsorGI Windows, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-15

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