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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30, 90, 180, and 360
Awards & highlights

Study Summary

This trial is testing a new weight-loss surgery method on up to 35 obese people with or without diabetes. The surgery will be done using the MAGNET System, and patients will be followed for 12 months.

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.Check my eligibility
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.See study design
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
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I am between 18 and 65 years old.
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I agree not to have weight-related surgery for 1 year.
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I agree to use birth control for 1 year to avoid pregnancy.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility and performance measured by anastomosis success
Secondary outcome measures
Efficacy of metabolic improvement
Efficacy of weight loss
Quality of life improvement
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Side-to-side anastomosis duodeno-ileostomy diversion

Find a Location

Who is running the clinical trial?

GT Metabolic Solutions, Inc.Lead Sponsor
3 Previous Clinical Trials
54 Total Patients Enrolled
3 Trials studying Obesity
54 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me how many people are currently enrolled in this research project?

"That is correct, the clinical trial is ongoing and actively recruiting patients. The listing on clinicaltrials.gov shows that the trial was first posted on November 18th, 2021 and was last updated on April 4th, 2022. They are presently looking for 35 patients to participate at 2 sites."

Answered by AI

What are the prerequisites for joining this clinical trial?

"This trial is looking for 35 obese adults, aged 18 to 65, who also meet the following requirements: type 2 diabetes mellitus (T2DM) diagnosed by a hemoglobin A1c (HbA1c) level of 6.5% or higher, previous sleeve gastrectomy at least 12 months prior with weight regain, no previous sleeve gastrectomy but T2DM diagnosis, scheduled laparoscopic SADI-S procedure where duodeno-ileostomy is performed side-to-side with the MAGNET System and BMI of 40 or higher. Additionally, participants must agree not to have any additional"

Answered by AI

Are we currently enrolling patients in this research?

"This trial, which was first advertised on November 18th 2021, is still recruiting patients according to the latest update from clinicaltrials.gov on April 4th, 2022."

Answered by AI

Does this research project allow people who are over the age of 40 to enroll?

"In order to take part in this clinical trial, patients must be between 18-65 years old. There are 208 separate medical studies for individuals under 18 and 616 for those over 65."

Answered by AI

Who else is applying?

What site did they apply to?
Westmount Surgical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System
2021. "Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322122.
~14 spots leftby Apr 2025
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