What side effects are associated with this type of intervention?

Common treatments for obesity, such as sleeve gastrectomy and similar procedures that reduce stomach size and alter the digestive tract, can have several side effects. Short-term side effects include nausea, vomiting, and surgical complications like infections or bleeding. Long-term side effects may involve nutritional deficiencies in vitamins and minerals, gastrointestinal issues such as acid reflux, and more severe complications like staple line leaks or bowel obstructions.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity that involve reducing stomach size and altering the digestive tract. Notable among these are bariatric surgical procedures such as the Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and sleeve gastrectomy. These procedures are designed to promote weight loss by restricting food intake and/or altering nutrient absorption. Additionally, the FDA has approved pharmacologic treatments like orlistat, phentermine-topiramate, and liraglutide, which aid in weight loss through various mechanisms. The trial involving sleeve gastrectomy with side-to-side anastomosis duodeno-ileostomy using the MAGNET System is an innovative approach that combines these principles to enhance metabolic outcomes.

What other types of research exist?

Promising, novel alternatives to Sleeve Gastrectomy with Side-to-Side Anastomosis Duodeno-Ileostomy using the MAGNET System for obesity patients include: 1) Single Anastomosis Duodeno-Ileal Bypass with Sleeve (SADI-S), which combines sleeve gastrectomy with a single anastomosis duodeno-ileal bypass to enhance weight loss and metabolic outcomes. 2) Biliopancreatic Diversion with Duodenal Switch (BPD-DS), which involves a sleeve gastrectomy followed by rerouting the intestines to limit calorie absorption. Both procedures are effective for patients who have not achieved desired results with other bariatric surgeries.

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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

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

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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.

Exclusion Criteria

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

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I have high blood pressure, cholesterol issues, or sleep apnea that isn't well-managed.

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I have an active ulcer or tested positive for Helicobacter pylori.

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My severe heartburn or acid reflux doesn't improve with treatment.

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I am currently pregnant or breastfeeding.

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I use injectable insulin.

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I need long-term blood thinner medication (not including aspirin).

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I don't have any issues that would prevent the use of a gastroscope or catheters in my throat or stomach.

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My type 2 diabetes is not well-managed.

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I have had surgery on my intestines, colon, or duodenum, but not for weight loss.

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I have Barrett's disease.

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I have a condition or past surgery that makes the procedure unsafe for me.

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I have a large hiatal hernia.

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I have not had a stroke or mini-stroke in the last 6 months.

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I cannot have laparoscopic surgery due to a specific condition.

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I have no unhealed wounds or bleeding at the site for the magnet.

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I have inflammatory bowel disease or diverticulitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30, 90, 180, and 360

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

0 / 19Eligibility criteria met

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.