MagDI U.S. Registry

February 19, 2026 updated by: GT Metabolic Solutions, Inc.

Post-Market Assessment of the Incidence and Severity of Internal Hernia and Bowel Obstruction at One Year Following Use of the MagDI System to Create Side-to-Side Duodeno-Ileal Magnetic Compression Anastomoses (MagDI US Registry)

Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).

Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.

Study Type

Observational

Enrollment (Estimated)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Recruiting
        • Ventura Advanced Surgical Associates
        • Contact:
          • Hellmuth Billy
          • Phone Number: 805-676-9100
        • Principal Investigator:
          • Helmuth Billy, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40299
        • Recruiting
        • Baptist Healthcare System, Inc.
        • Contact:
        • Principal Investigator:
          • John Oldham, MD
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Philip Gachassin, MD
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Recruiting
        • Bariatric Specialists of the Carolinas
        • Contact:
        • Principal Investigator:
          • Paul Enochs, MD
    • Washington
      • Lynnwood, Washington, United States, 98036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All eligible patients in the U.S. who undergo a side-to-side duodeno-ileal anastomosis with the MagDI System.

Description

Inclusion Criteria:

  1. >21 years of age, at the time of informed consent.
  2. Body Mass Index (BMI) between 30-50 kg/m2.
  3. Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center.
  4. Participant has been informed of the nature of the registry.

Exclusion Criteria:

1. Participant does not provide informed consent to be enrolled and followed in the registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MagDI System
Participants who underwent the MagDI System procedure and consented to participate in the Registry
Device: Side-to-side duodenal-ileal anastomosis
Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Internal Hernia and Bowel Obstructions
Time Frame: From date of study index procedure through 360 days.
To assess and characterize incidence and severity of internal hernia and bowel obstruction at one year in U.S. patients treated with the MagDI System compared with the pre-market study (GTM-001) and scientific literature.
From date of study index procedure through 360 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GT Metabolic Solutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTM-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Internal Hernia

Clinical Trials on Side-to-side duodenal-ileal anastomosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe