MagDI U.S. Registry

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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06928545

Enrollment

106

Registered

2025-04-15

Start date

2025-03-28

Completion date

2027-04-01

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomosis, Surgical, Bowel Obstruction, Internal Hernia

Keywords

GT Metabolic, MagDI System, Magnetic Anastomosis

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.

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.

Interventions

DEVICESide-to-side duodenal-ileal anastomosis

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Internal Hernia and Bowel Obstructions	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.

Countries

United States

Contacts

CONTACTLisa Griffin Vincent, PhD, MA

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

CONTACTJosh Schumacher