Clinical trial NCT06232746: Magnetic Jejuno-Ileal Diversion Study ("MJI Study")
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Lead sponsor: GT Metabolic Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label single-center study enrolling up to 10 subjects in the Czech Republic
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility and performance of the side-to-side anastomosis for jejuno-ileal diversion using the DI Magnet System.
timeFrame: From date of study index procedure through 90 days
measure: Safety of the DI Magnet System
timeFrame: Procedure, Day 90, Day 180, Day 360
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: OB KLINIKA a.s.
Study officials:
References: