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Procedure

Duodenal-Ileal Diversion + Sleeve Gastrectomy for Obesity and Type 2 Diabetes

N/A

Waitlist Available

Research Sponsored by GI Windows, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period

Weight stable over 3-month period

Must not have

Pre-existing severe comorbid cardio-respiratory disease

Use of injectable insulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well weight loss and different metabolic indicators improve in people with obesity.

Who is the study for?

This trial is for adults aged 19-65 with obesity (BMI between 35 and 50) and type 2 diabetes diagnosed within the last decade. Participants must have stable weight, controlled related health issues like hypertension, and not be on insulin or planning pregnancy. They should commit to no other weight-affecting surgeries for two years.

What is being tested?

The study tests a Self Forming Magnetic Anastomosis System in a single group of participants across multiple centers. It aims to assess its effect on weight loss and metabolic changes in patients with obesity and type 2 diabetes.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical risks associated with gastrointestinal surgery such as infection, bleeding, reaction to materials used (nickel/titanium), or complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to become pregnant for 24 months and will use birth control.

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My weight has been stable for the last 3 months.

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I agree not to have weight loss or reconstructive surgery for 2 years.

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I am between 19 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart or lung condition.

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I use injectable insulin.

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I have had major surgery on my stomach, duodenum, liver area, pancreas, or right colon.

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I have type 1 diabetes or my type 2 diabetes is not well-controlled.

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I have a birth defect or developed an issue in my digestive system.

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My obesity is caused by a specific genetic or hormonal condition.

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I cannot have general anesthesia due to health risks.

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I have a condition that makes endoscopy unsafe for me.

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My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight Loss

Secondary study objectives

Absolute Weight Loss Measures

Albumin - Nutritional Status

BMI - Weight Loss Measures

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device PlacementExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Self Forming Magnetic (SFM) Anastomosis System

2021

N/A

~30

0 / 13Eligibility criteria met