MagDI Italian Study

NCT06613711 | Active Not Recruiting

• 1 other identifier: GTM-010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).

Conditions

Obesity; Type 2 Diabetes Mellitus (T2DM); Anastomosis

Keywords

GT Metabolic; Magnetic Anastomosis; MagDI System

Outcome Measures

Primary Outcomes (2)

• Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.

  The duodeno-ileal diversion will be considered feasible if it results in successful: * Placement of the Magnet System (≥ 90% alignment of magnets); and * Creation of a patent anastomosis confirmed radiologically, and * Passage of magnets without any surgical re-interventions. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.

  From date of study index procedure through 90 days

• Safety of the MagDI System

  Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: • All-cause mortality • Intestinal perforation and/or peritonitis • Intestinal obstruction • Life-threatening bleeding • Incidence of device malfunctions

  Procedure, Day 90, Day 180, Day 360

Study Arms (1)

Magnet System, DI Biofragmentable

EXPERIMENTAL

GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System)

Device: Magnet System, DI Biofragmentable

Interventions

Magnet System, DI Biofragmentable DEVICE

Anastomoses achieved by magnetic compression.

Magnet System, DI Biofragmentable

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Between 18-65 years of age, at the time of informed consent. 2. Body Mass Index (BMI) between 30-50 kg/m2. 3. Meets one of the following criteria:
• Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
• Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
• Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous sleeve gastrectomy and no plan to perform a concurrent sleeve gastrectomy.
• \. Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
• \. Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.

You may not qualify if:

• \. Type 1 diabetes. 2. Use of injectable insulin. 3. Uncontrolled Type 2 Diabetes Mellitus (T2DM). 4. Investigator plans to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure.
• \. Uncontrolled hypertension, dyslipidemia or sleep apnea. 6. Prior intestinal, colonic or duodenal surgery (other than bariatric). 7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy.
• \. Refractory gastro-esophageal reflux disease (GERD). 9. Barrett's disease. 10. Helicobacter pylori positive and/or active ulcer disease. 11. Large hiatal hernia. 12. Inflammatory bowel or colonic diverticulitis disease. 13. Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
• \. Any anomaly preventing / contraindicating endoscopic or laparoscopic access and procedures.
• \. Implantable pacemaker or defibrillator. 16. Psychiatric disorder, except well-controlled depression with medication for
• gt; 6 months. 17. History of substance abuse. 18. Pregnant, lactating, or planning pregnancy during the clinical investigation.
• Note: Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release).
• \. Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant medically unfit for the procedure, including 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 Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
• \. Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure.
• \. Any stroke/TIA ≤ 6 months prior to consent. 24. Requires chronic anticoagulation therapy (except aspirin). 25. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
• \. Recent tobacco or nicotine product cessation ≤ 3 months prior to informed consent.
• \. Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
• \. Participants with comorbidities that are likely to result in a life expectancy of ≤ 12 months.

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (4)

Policlinico San Marco

Bergamo, Italy

Location

Maria Cecilia Hispital

Cotignola, Italy

Location

San Raffaelle Hospital

Milan, Italy

Location

Ospedale Evangelco Betania

Naples, Italy

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label multicenter study enrolling up to 60 participants at up to 5 sites in Italy.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: September 20, 2024
• Primary Completion: June 17, 2025
• Study Completion: April 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)