MagDI Diversion Feasibility Study

NCT05692518 | Completed DMC

• 1 other identifier: GTM-005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System (MAGNET System, DI Bio-fragmentable) for creation of a side-by-side anastomosis duodeno-ileostomy in obese adults.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Creation of a patent anastomosis

  Confirmed radiologically or fluoroscopically

  30 Days

Study Arms (1)

MAGNET System, DI Bio-fragmentable

EXPERIMENTAL

GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System

Device: MAGNET System, DI Bio-fragmentable

Interventions

MAGNET System, DI Bio-fragmentable DEVICE

Anastomoses achieved by magnetic compression.

MAGNET System, DI Bio-fragmentable

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 30-35 kg/m2
• Type 2 diabetes mellitus (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
• Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-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 mo

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (1)

Innova Medical Center

Tbilisi, Georgia, N.6, Georgia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Single-center, open-label, single-arm, feasibility device study.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: December 19, 2022
• Primary Completion: August 23, 2024
• Study Completion: May 20, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

GE (1)