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

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable) to Achieve Jejuno-Ileal Diversion in Adults With Obesity and Type 2 Diabetes Mellitus: MJI Study

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Device: Magnet System, DI Biofragmentable

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Griffin Vincent, PhD; Phone Number: +1 763-200-1416; Email: clinical@gtmetabolic.com
• Study Contact Backup: Name: Josh Schumacher; Phone Number: +1 763-200-1416; Email: clinical@gtmetabolic.com

Study Locations

• Czechia
  • Prague, Czechia, 130 00
    • Recruiting
    • OB KLINIKA a.s.
    • Contact: Martin Fried, MD; Phone Number: +420 255 725 125; Email: docfried@volny.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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)

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: Magnet System, DI Biofragmentable; GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (Magnet System, DI Biofragmentable)	Device: Magnet System, DI Biofragmentable; Anastomoses achieved by magnetic compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GT Metabolic Solutions, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus, Type 2; Obesity
• Other Study ID Numbers: GTM-008

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