← Back to Search

Magnetic Anastomosis System

Magnetic Anastomosis Weight-Loss Surgery for Obesity

N/A
Waitlist Available
Led By Michel Gagner, MD
Research Sponsored by GT Metabolic Solutions, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years of age, inclusive, at the time of informed consent
Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for 1 year
Must not have
Uncontrolled hypertension, dyslipidemia or sleep apnea
Helicobacter pylori positive and/or active ulcer disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30, 90, 180, and 360
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new weight-loss surgery using the MAGNET System. It targets adults with obesity, especially those with type 2 diabetes or who have regained weight after previous surgery. The surgery reduces stomach size and changes food digestion pathways to help lose weight. Magnetic devices have been successfully used in bariatric surgery, primarily for liver retraction.

Who is the study for?
This trial is for adults aged 18-65 with obesity (BMI 30-50), who may also have type 2 diabetes. It's open to those who've had a previous sleeve gastrectomy and experienced weight regain or have T2DM, as well as those without prior surgery but with T2DM, or are undergoing SADI-S. Participants must not plan other weight-affecting surgeries for a year, use contraception if applicable, and be able to follow the study rules.
What is being tested?
The trial tests a side-to-side anastomosis duodeno-ileostomy procedure using the MAGNET System in patients undergoing sleeve gastrectomy. Up to 50 participants at multiple centers will be monitored over one year to assess the effectiveness of this new surgical technique in managing obesity.
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with bariatric surgery include infection, bleeding, nutrient deficiencies, gastrointestinal issues like nausea and vomiting, and potential complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I agree not to have weight-related surgery for 1 year.
Select...
I agree to use birth control for 1 year to avoid pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have high blood pressure, cholesterol issues, or sleep apnea that isn't well-managed.
Select...
I have an active ulcer or tested positive for Helicobacter pylori.
Select...
My severe heartburn or acid reflux doesn't improve with treatment.
Select...
I am currently pregnant or breastfeeding.
Select...
I use injectable insulin.
Select...
I need long-term blood thinner medication (not including aspirin).
Select...
I don't have any issues that would prevent the use of a gastroscope or catheters in my throat or stomach.
Select...
My type 2 diabetes is not well-managed.
Select...
I have had surgery on my intestines, colon, or duodenum, but not for weight loss.
Select...
I have Barrett's disease.
Select...
I have a condition or past surgery that makes the procedure unsafe for me.
Select...
I have a large hiatal hernia.
Select...
I have not had a stroke or mini-stroke in the last 6 months.
Select...
I cannot have laparoscopic surgery due to a specific condition.
Select...
I have no unhealed wounds or bleeding at the site for the magnet.
Select...
I have inflammatory bowel disease or diverticulitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30, 90, 180, and 360
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30, 90, 180, and 360 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility and performance measured by anastomosis success
Secondary study objectives
Efficacy of metabolic improvement
Efficacy of weight loss
Quality of life improvement
+1 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: TreatmentExperimental Treatment1 Intervention
Side-to-side anastomosis duodeno-ileostomy diversion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Side-to-side anastomosis duodeno-ileostomy diversion procedure
2021
N/A
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bariatric surgeries, such as Sleeve Gastrectomy with Side-to-Side Anastomosis Duodeno-Ileostomy using the MAGNET System, primarily work by reducing the size of the stomach and altering the digestive tract. This reduction in stomach size limits food intake and promotes early satiety, while the alteration of the digestive tract can change nutrient absorption and hormone levels, leading to improved metabolic outcomes. These mechanisms are crucial for obesity patients as they not only facilitate significant weight loss but also help in the remission of obesity-related comorbidities like type 2 diabetes, thereby improving overall health and quality of life.
Magnetic device in reduced port and single port bariatric surgery: First 170 cases experience.

Find a Location

Who is running the clinical trial?

GT Metabolic Solutions, Inc.Lead Sponsor
7 Previous Clinical Trials
243 Total Patients Enrolled
7 Trials studying Obesity
243 Patients Enrolled for Obesity
Michel Gagner, MDPrincipal InvestigatorWestmount Surgical Center

Media Library

Side-to-side anastomosis duodeno-ileostomy diversion procedure (Magnetic Anastomosis System) Clinical Trial Eligibility Overview. Trial Name: NCT05322122 — N/A
Obesity Research Study Groups: Treatment
Obesity Clinical Trial 2023: Side-to-side anastomosis duodeno-ileostomy diversion procedure Highlights & Side Effects. Trial Name: NCT05322122 — N/A
~13 spots leftby Oct 2025