Recruiting

MagDI System

Sponsor:

GT Metabolic Solutions, Inc.

Code:

NCT06928545

Conditions

Anastomosis, Surgical

Internal Hernia

Bowel Obstruction

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Side-to-side duodenal-ileal anastomosis

Study Details

Brief summary:

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.

Conditions

Anastomosis, Surgical

Internal Hernia

Bowel Obstruction

Study ID

NCT06928545

Start date

Mar 28, 2025

Status verified date

Feb, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

106 participants

Anticipated

Interventions and Outcome Measures

Arms

MagDI System

Participants who underwent the MagDI System procedure and consented to participate in the Registry

Interventions

Side-to-side duodenal-ileal anastomosis

Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.

Primary outcome measure

  • Incidence of Internal Hernia and Bowel Obstructions [ Time Frame: From date of study index procedure through 360 days. ]

Central Contacts and Locations

Central contacts

Lisa Griffin Vincent, PhD, MA

+1 763-200-1416clinical@gtmetabolic.com

Josh Schumacher

+1 763-200-1416clinical@gtmetabolic.com

Locations

Ventura Advanced Surgical Associates

Recruiting

Ventura, California, United States, 93003

Contacts

Hellmuth Billy

805-676-9100

Principal Investigator:

Helmuth Billy, MD

Baptist Healthcare System, Inc.

Recruiting

Louisville, Kentucky, United States, 40299

Contacts

Candice Brunton

candice.brunton@bhsi.com

Principal Investigator:

John Oldham, MD

Ochsner Clinic Foundation

Recruiting

Lafayette, Louisiana, United States, 70503

Contacts

Ashunti Pearson

aspearson@ochsner.org

Principal Investigator:

Philip Gachassin, MD

Bariatric Specialists of the Carolinas

Recruiting

Cary, North Carolina, United States, 27518

Contacts

Jamie Lee Bull, PA

jbullpabsc@gmail.com

Principal Investigator:

Paul Enochs, MD

Transform Weight Loss

Recruiting

Lynnwood, Washington, United States, 98036

Contacts

Josiah Billing

jbilling@transformweightloss.com

Principal Investigator:

Peter Billing, MD

More Information

Sponsor

GT Metabolic Solutions, Inc.

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • GT Metabolic
  • MagDI System
  • Magnetic Anastomosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GT Metabolic Solutions, Inc. on 2026-02-20.