Clinical trial NCT06613711: MagDI Italian Study
Official title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Italy to Achieve Duodeno-Ileal Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus (MagDI Italy Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes Mellitus (T2DM)
Anastomosis
Keywords: GT Metabolic
Magnetic Anastomosis
MagDI System
Lead sponsor: GT Metabolic Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 60
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 multicenter study enrolling up to 60 participants at up to 5 sites in Italy.
Primary purpose: TREATMENT

Brief summary: The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).

Detailed description: The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).

The partial diversion of intestinal contents from the duodenum to the ileum via side-to-side duodeno-ileostomy is intended to facilitate weight management / loss in obese adults and improve metabolic outcomes in obese adults with or without type 2 diabetes mellitus (T2DM). Side-to-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. The most common side-to-side anastomosis technique used today is stapling, requiring cutting of the intestines and staples remain behind in the body. Linear staplers are available in different sizes (e.g., 30mm, 45mm, 50mm, 60mm). A predicate for this side-to-side duodeno-ileostomy diversion procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.

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%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
2. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
3. Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous sleeve gastrectomy and no plan to perform a concurrent sleeve gastrectomy.

   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.

   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
     * gt; 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.

Primary outcomes:
measure: Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.
timeFrame: From date of study index procedure through 90 days
measure: Safety of the MagDI System
timeFrame: Procedure, Day 90, Day 180, Day 360
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Policlinico San Marco
city: Cotignola
country: Italy
facility: Maria Cecilia Hispital
city: Milano
country: Italy
facility: San Raffaelle Hospital
city: Naples
country: Italy
facility: Ospedale Evangelco Betania
Study officials:
References: