Magnetic Jejuno-Ileal Diversion Study ("MJI Study")

NCT06232746 | Completed

• 1 other identifier: GTM-008
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable and hereafter referred to as the DI Magnet System) for creation of a side-to-side jejuno-ileal anastomosis in adults with obesity and type 2 diabetes mellitus (T2DM).

Conditions

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Feasibility and performance of the side-to-side anastomosis for jejuno-ileal diversion using the DI Magnet System.

  The jejuno-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 participants.

  From date of study index procedure through 90 days

• Safety of the DI Magnet 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 DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable)

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:

• years of age, inclusive, at the time of informed consent
• BMI 30-40 kg/m2
• T2DM (defined as HbA1c ≥ 6.5%) without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy
• Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
• If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
• Willing and able to comply with protocol requirements

You may not qualify if:

• Type 1 diabetes
• Use of injectable insulin
• Uncontrolled T2DM
• Plan to perform a sleeve gastrectomy with the jejuno-ileal anastomosis procedure
• 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 disorder, except well-controlled depression with medication for \> 6 months

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (1)

OB KLINIKA a.s.

Prague, 130 00, Czechia

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 single-center study enrolling up to 10 subjects in the Czech Republic

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: February 13, 2024
• Primary Completion: September 24, 2024
• Study Completion: June 24, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)