Magnetic Duodeno-Ileal Chile Study

NCT06613724 | Completed

• 1 other identifier: GTM-012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the MagDI Chile 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 Mellitus (T2DM)

Keywords

GT Metabolic; MagDI System; Magnetic Anastomosis

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%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
• Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
• 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.
• 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.

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 (1)

Clinica MEDS La Dehesa SpA

Santiago, Chile

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 40 participants at up to 3 sites in Chile.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: October 14, 2024
• Primary Completion: February 27, 2025
• Study Completion: December 4, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)