Evaluating a new system for weight management in obese adults

Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Australia to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus (MagDI Australia Study)

This study is testing a new magnet system for weight management in obese adults who are having a specific type of surgery to see if it can help them lose weight and improve their diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: GT Metabolic Solutions, Inc. (Industry-sponsored)
• Locations: 4 sites (Sydney, New South Wales and 3 other locations)
• Trial ID: NCT06473831 on ClinicalTrials.gov

What this trial studies

The MagDI Australia Study aims to assess the feasibility, safety, and initial efficacy of the MagDI System in participants undergoing a specific surgical procedure known as duodeno-ileal side-to-side anastomosis. This procedure is designed to facilitate partial intestinal diversion to aid in weight management and improve metabolic outcomes in obese adults, particularly those with type 2 diabetes. The study will involve participants aged 18-65 with a BMI between 30-50 kg/m2, who meet specific criteria related to their diabetes status and previous weight loss surgeries. The intervention will utilize a magnet system to create the anastomosis, potentially offering a less invasive alternative to traditional methods.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 with a BMI between 30-50 kg/m2, who have type 2 diabetes or have experienced weight regain after previous bariatric surgery.

Not a fit: Patients who are not eligible include those outside the specified age range, those with a BMI below 30 or above 50, and individuals who are not indicated for a duodenal ileal anastomosis procedure.

Why it matters

Potential benefit: If successful, this study could provide a new surgical option for effective weight management and improved metabolic health in obese patients.

How similar studies have performed: While similar surgical approaches have been explored, the specific use of the MagDI System for this procedure is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Between 18-65 years of age, at the time of informed consent.
2. Body Mass Index (BMI) between 30-50 kg/m2
3. Meets one of the following criteria:

   1. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) following previous sleeve gastrectomy (≥ 12 months); OR
   2. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy.
   3. Weight regain following previous sleeve gastrectomy (≥ 12 months).
4. Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
5. Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.
6. Participant is indicated for, and has agreed to, a bariatric procedure involving a duodenal ileal anastomosis. The participant has also undergone the site standard of care evaluation for this type of procedure, which is expected to involve clinical assessments over a period of time by a multidisciplinary team and may include, but is not limited to, the following: screening for surgical safety, interviews to determine if the participant understands the procedure and post-operative demands, and whether the participant has the necessary social supports in place to help manage outcomes.

Exclusion Criteria:

1. Type 1 diabetes.
2. Use of injectable insulin.
3. Uncontrolled Type 2 Diabetes Mellitus (T2DM).
4. Investigator plans 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 contraindicate 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. Any anomaly preventing / contraindicating endoscopic or laparoscopic access and procedures.
15. Implantable pacemaker or defibrillator.
16. Psychiatric disorder, except well-controlled depression with medication for \> 6 months.
17. History of substance abuse.
18. Pregnant, lactating, or planning pregnancy during the clinical investigation. Note: Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release).
19. Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant 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 Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
22. Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure.
23. Any stroke/TIA ≤ 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. Recent tobacco or nicotine product cessation ≤ 3 months prior to informed consent.
27. Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
28. Participants with comorbidities that are likely to result in a life expectancy of ≤ 12 months.
29. Currently participating in an investigational drug or another device study that has not reached its primary endpoint: Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
30. A positive COVID-19 test prior to the study procedure in accordance with local COVID-19 protocol.
31. Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Where this trial is running

Sydney, New South Wales and 3 other locations

• Dr. Mark Magdy (affiliated with St. George Private Hospital) — Sydney, New South Wales, Australia (Recruiting)
• Calvary Health Care Adelaide Limited — Adelaide, Australia (Recruiting)
• St. John of God - Murdoch Hospital — Perth, Australia (Recruiting)
• Upper GI Surgery — Sydney, Australia (Recruiting)

Study contacts

• Study coordinator: Lisa Griffin Vincent, PhD

Conditions Obesity; Type 2 Diabetes