Obesity / Type 2 Diabetes / Magnet System, DI Biofragmentable · Interventional Study

MagDI Australia Study

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a completed single-arm feasibility study of a novel magnetic anastomosis device (MagDI System) in 25 participants with obesity and type 2 diabetes. The record documents the study design, planned primary outcomes (procedural feasibility, safety, and initial efficacy), and follow-up through 360 days, but no results are posted in this registry entry.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Obesity, Type 2 Diabetes; age from 18 Years; to 65 Years. Intervention: Magnet System, DI Biofragmentable. n = 25. 4 sites: Australia.

Key findings

Safety

Results are not posted in this registry record; no efficacy, safety, or feasibility data are reported.

Who this may help

No clinical impact can be assessed from this registry record alone, as results are not posted. Readers should await publication of feasibility, safety, and efficacy outcomes before considering clinical application.

Plain-language summary

Registry record of a completed single-arm feasibility study in a small population (n=25) evaluating a novel device; no results are posted, and the primary focus is procedural feasibility and safety rather than clinical efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System. (assessed at From date of study index procedure through 90 days); Safety of the MagDI System (assessed at Procedure, Day 90, Day 180, Day 360)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationObesity, Type 2 Diabetes; age from 18 Years; to 65 Years

Sample size25

InterventionMagnet System, DI Biofragmentable

Setting4 sites: Australia

Reported figures

Quoted from the source exactly as published.

Planned sample size25

Primary outcome – feasibility and performanceSide-to-side anastomosis for duodeno-ileal diversion using MagDI System

Primary outcome – safety assessmentDay 90, Day 180, Day 360

Follow-up durationThrough 360 days

Clinical bottom line

Caveats

Results are not posted in this registry record; no efficacy, safety, or feasibility data are reported.
Single-arm design without control or comparator group limits ability to infer clinical benefit.
Small sample size (n=25) is appropriate for feasibility but insufficient for definitive efficacy claims.
Study is described as 'NA' phase, consistent with early-stage device development; regulatory pathway and intended use are not specified in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm interventional study; no control group or comparator arm.

Directness

moderate

Addresses a specific procedural outcome (anastomosis feasibility) in intended population with obesity and type 2 diabetes.

Consistency

insufficient

Registry record only; no results reported, so consistency cannot be assessed.

Risk of bias

insufficient

No results or methodology detail provided to assess bias; registry record does not describe blinding or allocation.

Sample adequacy

limited

Planned enrollment 25 participants; typical for early-stage device feasibility but insufficient for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06473831). This is a study registration, not published results. Lead sponsor: GT Metabolic Solutions, Inc.. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 25 participants (ACTUAL). Conditions: Obesity, Type 2 Diabetes. Interventions: DEVICE: Magnet System, DI Biofragmentable. Primary outcome measures: Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System. , From date of study index procedure through 90 days; Safety of the MagDI System , Procedure, Day 90, Day 180, Day 360. 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityNCT06473831Type 2 DiabetesMagnet System, DI BiofragmentableGT Metabolic Solutions