MagDI Australia Study

NCT06473831 | Active Not Recruiting

• 1 other identifier: GTM-009
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of the MagDI Australia 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).

Conditions

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.

  The duodeno-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 subjects.

  From date of study index procedure through 90 days

• Safety of the MagDI 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

Study Arms (1)

Magnet System, DI Biofragmentable

EXPERIMENTAL

GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System)

Device: Magnet System, DI Biofragmentable

Interventions

Magnet System, DI Biofragmentable DEVICE

Anastomoses achieved by magnetic compression.

Magnet System, DI Biofragmentable

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-65 years of age, at the time of informed consent.
• Body Mass Index (BMI) between 30-50 kg/m2
• Meets one of the following criteria:
• Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) following previous sleeve gastrectomy (≥ 12 months); OR
• Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy.
• Weight regain following previous sleeve gastrectomy (≥ 12 months).
• Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
• 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.
• 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.

You may not qualify if:

• Type 1 diabetes.
• Use of injectable insulin.
• Uncontrolled Type 2 Diabetes Mellitus (T2DM).
• Investigator plans to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure.
• Uncontrolled hypertension, dyslipidemia or sleep apnea.
• Prior intestinal, colonic or duodenal surgery (other than bariatric).
• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy.
• Refractory gastro-esophageal reflux disease (GERD).
• Barrett's disease.
• Helicobacter pylori positive and/or active ulcer disease.
• Large hiatal hernia.
• Inflammatory bowel or colonic diverticulitis disease.
• Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
• Any anomaly preventing / contraindicating endoscopic or laparoscopic access and procedures.
• Implantable pacemaker or defibrillator.

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (4)

Dr. Mark Magdy (affiliated with St. George Private Hospital)

Sydney, New South Wales, 2217, Australia

Location

St. John of God Health Care, Inc.

Murdoch, Western Australia, 6150, Australia

Location

Calvary Health Care Adelaide Limited

Adelaide, Australia

Location

Upper GI Surgery

Sydney, Australia

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label multicenter study enrolling up to 30 participants at up to 3 sites in Australia.

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: August 13, 2024
• Primary Completion: September 4, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)