Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus

GI Windows

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Obesity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04627103

GIW 20-001

Details and patient eligibility

About

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

Full description

Multi-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 with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)

Enrollment: 18 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 19-65 years at screening
• Body mass index (BMI) ≥35 and ≤50
• T2DM diagnosis ≥6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but < 10.0% at time of enrollment.
• HbA1c must be stable over a 3-month period.
• Weight stable over 3-month period
• Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled
• 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
• Type 1 diabetes or poorly controlled type 2 diabetes
• Use of injectable insulin
• Any documented conditions for which endoscopy would be contraindicated
• Contraindication to general anesthesia
• History of chronic gastrointestinal disease
• Congenial or acquired anomalies of the GI tract
• Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
• Uncontrolled hypertension
• Pre-existing severe comorbid cardio-respiratory disease
• 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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18 participants in 1 patient group

Device Placement

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. Following the diversion creation, a sleeve gastrectomy will also be performed.

Treatment:

Device: Self Forming Magnetic (SFM) Anastomosis System