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CompletedNCT06232746Updated Dec 23, 2025

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

An interventional study of Magnet System, DI Biofragmentable in Obesity and Type 2 Diabetes, sponsored by GT Metabolic Solutions, Inc.. Completed at 1 site in Czechia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by GT Metabolic Solutions, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the detailed description

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). This partial diversion of intestinal contents from jejunum to the ileum is intended to facilitate weight management/loss and improve metabolic outcomes. Side-by side anastomoses are currently created by sutures, staples, and anastomotic compression devices. This study explores a partial jejuno-ileal diversion procedure creating a side-to-side anastomosis with magnetic compression anastomosis.

02

Conditions studied

  • Obesity
  • Type 2 Diabetes
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 9 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

GT Metabolic Solutions, Inc. is the lead sponsor of 14 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18-65 years of age, inclusive, at the time of informed consent
  2. BMI 30-40 kg/m2
  3. T2DM (defined as HbA1c ≥ 6.5%) without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy
  4. Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
  5. If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
  6. Willing and able to comply with protocol requirements

Exclusion criteria

Exclusion Criteria:

  1. Type 1 diabetes
  2. Use of injectable insulin
  3. Uncontrolled T2DM
  4. Plan to perform a sleeve gastrectomy with the jejuno-ileal anastomosis procedure
  5. 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 contra-indicate the procedure, including scarring and abnormal anatomy.
  8. 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.
  14. Implantable pacemaker or defibrillator
  15. Psychiatric disorder, except well-controlled depression with medication for > 6 months
  16. History of substance abuse
  17. Woman who is either pregnant or breast feeding
  18. Woman of childbearing potential who does not agree to use an effective method of contraception.
  19. 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, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the magnets.
  20. Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target magnet deployment site
  21. Expected need for MR imaging within the first 2 months after the procedure
  22. Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures
  23. Had surgical or interventional procedure within 30 days prior to procedure
  24. Any scheduled surgical or interventional procedure planned within 30 days postprocedure
  25. Any stroke/TIA within 6 months prior to consent
  26. Requires chronic anticoagulation therapy (except aspirin)
  27. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
  28. Unable to comply with the follow-up schedule and assessments
  29. Recent tobacco or nicotine product cessation within \< 3 months prior to informed consent
  30. Known allergies to the device components or contrast media
  31. Limited life expectancy due to terminal disease
  32. Currently participating in another clinical research study with an investigational drug or medical device
  33. Any condition that, in the investigator's opinion, may preclude completion of followup 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Magnet System, DI Biofragmentable

    GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable)

    Device: Magnet System, DI Biofragmentable

Interventions

  • DeviceMagnet System, DI Biofragmentable

    Anastomoses achieved by magnetic compression.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From date of study index procedure through 90 days

  2. 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

    Time frame: Procedure, Day 90, Day 180, Day 360

07

Study locations

1 site
  • OB KLINIKA a.s.
    Prague, 130 00, Czechia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06232746
Lead sponsor
GT Metabolic Solutions, Inc.
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Feb 13, 2024
Primary completion
Sep 24, 2024
Completion
Jun 24, 2025
Last update
Dec 23, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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