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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232746
• Other study ID #: GTM-008
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: GT Metabolic Solutions, Inc.
• Contact: Lisa Griffin Vincent, PhD
• Phone: +1 763-200-1416
• Email: clinical[@]gtmetabolic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Device:
• Magnet System, DI Biofragmentable
Anastomoses achieved by magnetic compression.

Locations

Country	Name	City	State
Czechia	OB KLINIKA a.s.	Prague

Sponsors (1)

Lead Sponsor	Collaborator
GT Metabolic Solutions, Inc.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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