Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (MAGNET System) to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus

This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy (revision or de novo) with side-to-side anastomosis duodeno-ileostomy using the MAGNET System and will be followed for 12 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Device: Side-to-side anastomosis duodeno-ileostomy diversion procedure

Detailed Description

The MAGNET study is an operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe as follows:

• Stage 1 first-in-human (FIH) and proof-of-concept with 5 subjects; and
• Stage 2 feasibility with 45 subjects.

There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.

Study Procedure: Side-to-side anastomosis duodeno-ileostomy diversion procedure using the MAGNET System

Study Population: Adults (18 to 65 years of age, inclusive) with obesity (BMI 30-50) who meet one of the following criteria: (1) have type 2 diabetes mellitus (T2DM) or experienced weight regain following previous sleeve gastrectomy; (2) have T2DM without previous sleeve gastrectomy; or (3) are candidates for a laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) procedure and have BMI ≥ 40.

Follow-up: Each subject will return for 6 follow-up visits at Day 14, 30, 60, 90, 180, 270 and 360 (end of study).

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Schwartz, MS; Email: dan@gtmetabolic.com
• Study Contact Backup: Name: Lisa Griffin Vincent, PhD; Phone Number: +16122224200; Email: lgv@gtmetabolic.com

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Chu St Pierre
• Canada
  • Quebec
    • Westmount, Quebec, Canada, H3Z 2P9
      • Westmount Surgical Center
• Georgia
  • Tbilisi, Georgia, N.6
    • Innova Medical Center
• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos Complutense University of Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years of age, inclusive, at the time of informed consent

• BMI 30-50, inclusive with either:

  • Previous-sleeve gastrectomy (> 12 months) with either T2DM (defined as HbA1c > 6.5%) or weight regain; or
  • T2DM without previous gastrectomy; or
  • Undergoing laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) where duodeno-ileostomy is performed side to side with the MAGNET System and BMI > 40
• Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for 1 year
• If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for 1 year
• Willing and able to comply with protocol requirements

Exclusion Criteria:

• Type 1 diabetes
• Use of injectable insulin
• Uncontrolled T2DM
• Uncontrolled hypertension, dyslipidemia or sleep apnea
• Prior intestinal, colonic or duodenal surgery, other than bariatric
• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra- indicate the procedure, including scarring and abnormal anatomy
• Refractory gastro-esophageal reflux disease (GERD)
• Barrett's disease
• Helicobacter pylori positive and/or active ulcer disease
• Large hiatal hernia
• Inflammatory bowel or colonic diverticulitis disease
• Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques
• Implantable pacemaker or defibrillator
• Psychiatric disorders, except well-controlled depression with medication for >6mo, or history of substance abuse
• Woman who is either pregnant or breast feeding
• Woman of childbearing potential who does not agree to use an effective method of contraception
• Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure. This includes any conditions for which endoscopic or laparoscopic surgery would be contraindicated, and any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the magnets.
• Unhealed ulcers, bleeding lesions, tumor or any other lesion at target magnet deployment site
• Expected need for MR imaging within the first 2 months after the procedure
• Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic procedures
• Had surgical or interventional procedure within 30 days prior to procedure
• Any scheduled surgical or interventional procedure planned within 30 days post-procedure
• Any stroke/TIA within 6 months prior to consent
• Requires chronic anticoagulation therapy (except aspirin)
• Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
• Unable to comply with the follow-up schedule and assessments
• Recent tobacco or nicotine product cessation within < 3 months prior to informed consent
• Known allergies to the device components or contrast media
• Limited life expectancy due to terminal disease
• Currently participating in another clinical research study with an investigational drug or medical device
• A positive COVID-19 test prior to the study procedure
• Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Side-to-side anastomosis duodeno-ileostomy diversion	Device: Side-to-side anastomosis duodeno-ileostomy diversion procedure; Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (The MAGNET System) to Achieve Duodeno-Ileostomy Diversion.; Other Names: The MAGNET System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and performance measured by anastomosis success	The primary feasibility/performance endpoint is the feasibility/performance of side-to-side anastomosis duodeno-ileostomy defined as: Placement of the MAGNET System (≥ 90% alignment of magnets); and; Passage of magnets without surgical re-intervention; and; Creation of a patent anastomosis, confirmed radiologically. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of the MAGNET System	The incidence of treatment emergent AEs and SAEs is a standard measure of the safety. The incidence of device malfunction informs about the device reliability.	Day 30, 90, 180, and 360
Efficacy of weight loss	Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in total weight loss and excess weight loss (EWL)	Day 90, 180, and 360
Efficacy of metabolic improvement	Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in functional improvement of metabolic indicators (HbA1c, blood glucose)	Day 90, 180, and 360
Quality of life improvement	Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in quality of life improvement (SF-36)	Day 90, 180, and 360

Collaborators and Investigators

• Sponsor: GT Metabolic Solutions, Inc.
• Investigators: Principal Investigator: Michel Gagner, MD, Westmount Surgical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): June 22, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: GTM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No