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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight Loss
Secondary outcome measures
Absolute Weight Loss Measures
Albumin - Nutritional Status
BMI - Weight Loss Measures
+10 moreTrial 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.
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Who is running the clinical trial?
GI Windows, Inc.Lead Sponsor
7 Previous Clinical Trials
522 Total Patients Enrolled
1 Trials studying Obesity
15 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My obesity-related health issues like high blood pressure, cholesterol problems, or sleep apnea are under control.I have a long-term stomach or intestine disease.I agree not to become pregnant for 24 months and will use birth control.I have a serious heart or lung condition.Your blood sugar levels must stay steady for 3 months.I use injectable insulin.I have had major surgery on my stomach, duodenum, liver area, pancreas, or right colon.I have type 1 diabetes or my type 2 diabetes is not well-controlled.My weight has been stable for the last 3 months.I have a birth defect or developed an issue in my digestive system.You have a known or suspected allergy to nickel, titanium, or nitinol.You quit using tobacco or nicotine products within the last 3 months.I agree not to have weight loss or reconstructive surgery for 2 years.Your body mass index (BMI) is between 35 and 50.My obesity is caused by a specific genetic or hormonal condition.I cannot have general anesthesia due to health risks.I have a condition that makes endoscopy unsafe for me.I have had type 2 diabetes for more than 6 months but less than 10 years, and my HbA1c is between 6.5% and 10%.I am between 19 and 65 years old.My high blood pressure is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Device Placement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my participation in this research endeavor possible?
"This research initiative is currently accepting applications from 40 individuals aged 19-65 who are obese. The most important criteria for this study include a BMI between 35 and 50, being weight stable over the past 3 months, having any obesity related comorbidities well managed, agreeing to abstain from bariatric surgery or reconstructive procedures that would affect their bodyweight in the two year period of involvement with the trial."
Answered by AI
How many participants are being welcomed into this trial?
"Affirmative. As per the details present on clinicaltrials.gov, this research endeavour was first posted in October 2021 and is now actively continuing recruitment efforts. 40 individuals are needed to be enlisted from 2 different trial sites."
Answered by AI
Are there any remaining vacancies in this clinical trial?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, first posted on October 7th 2021, is currently seeking participants. They require 40 patients to participate from two distinct sites."
Answered by AI
Does this trial accommodate participants aged 18 or older?
"This medical trial is designed for individuals aged 19 to 65. However, there are ancillary clinical trials with 379 opportunities available for minors and 1,629 studies open to those over the age of retirement."
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