MagDI Diversion Feasibility Study

Obesity Clinical Trial

Official title:

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Bio-fragmentable Magnetic Anastomosis System to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05692518
• Other study ID #: GTM-005
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: February 15, 2025

Study information

• Verified date: January 2024
• Source: GT Metabolic Solutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-by-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: February 15, 2025
• Est. primary completion date: December 31, 2024
• 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 30-35 kg/m2

3. Type 2 diabetes mellitus (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. Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-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 mo

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.

20. Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic procedures

21. Had surgical or interventional procedure within 30 days prior to procedure

22. Any scheduled surgical or interventional procedure planned within 30 days post-procedure

23. Any stroke/transient ischemic attack (TIA) within 6 months prior to consent

24. Requires chronic anticoagulation therapy (except aspirin)

25. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure

26. Unable to comply with the follow-up schedule and assessments

27. Recent tobacco or nicotine product cessation within < 3 months prior to informed consent

28. Known allergies to the device components or contrast media

29. Limited life expectancy due to terminal disease

30. Currently participating in another clinical research study with an investigational drug or medical device

31. A positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 or COVID-19) test prior to the study procedure in accordance with local COVID-19 protocol

32. Any condition that, in the investigator's opinion, may preclude completion of follow-up 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 Bio-fragmentable
Anastomoses achieved by magnetic compression.

Locations

Country	Name	City	State
Georgia	Innova Medical Center	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
GT Metabolic Solutions, Inc.

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a patent anastomosis	Confirmed radiologically or fluoroscopically	30 Days