Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy (SNAP-PS)

GI Windows

Status: Completed

Conditions: Obesity, Morbid

Treatments: Device: Self Forming Magnetic (SFM) Anastomosis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05049824

GIW 19-001

Details and patient eligibility

About

Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.

Full description

Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.

Enrollment: 27 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 22-65 years at screening
• Body mass index (BMI) ≥35 and ≤50
• Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain.
• Weight stable over 3-month period
• Negative H. pylori breath test
• Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
• If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
• Able to understand and sign informed consent documents.

Exclusion criteria

• Known or suspected allergy to nickel or titanium or nitinol
• Contraindication to general anesthesia
• Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series
• Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
• Clinically significant findings during screening endoscopy at target region for compression anastomosis
• Uncontrolled hypertension
• Pre-existing severe comorbid cardio-respiratory disease
• History of type 1 diabetes or poorly controlled type 2 diabetes
• Abnormal liver biochemistry
• History of chronic gastrointestinal disease
• Specific genetic or hormonal cause of obesity
• Recent tobacco/nicotine product cessation (within 3 months prior)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

SFM Treatment Arm

Experimental group

Description:

The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion

Treatment:

Device: Self Forming Magnetic (SFM) Anastomosis System