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)
1 other identifier
observational
106
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2025
CompletedFirst Submitted
Initial submission to the registry
April 8, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 20, 2026
February 1, 2026
1.9 years
April 8, 2025
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Internal Hernia and Bowel Obstructions
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.
Study Arms (1)
MagDI System
Participants who underwent the MagDI System procedure and consented to participate in the Registry
Interventions
Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
Eligibility Criteria
All eligible patients in the U.S. who undergo a side-to-side duodeno-ileal anastomosis with the MagDI System.
You may qualify if:
- \>21 years of age, at the time of informed consent.
- Body Mass Index (BMI) between 30-50 kg/m2.
- Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center.
- Participant has been informed of the nature of the registry.
You may not qualify if:
- \. Participant does not provide informed consent to be enrolled and followed in the registry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Ventura Advanced Surgical Associates
Ventura, California, 93003, United States
Baptist Healthcare System, Inc.
Louisville, Kentucky, 40299, United States
Ochsner Clinic Foundation
Lafayette, Louisiana, 70503, United States
Bariatric Specialists of the Carolinas
Cary, North Carolina, 27518, United States
Transform Weight Loss
Lynnwood, Washington, 98036, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2025
First Posted
April 15, 2025
Study Start
March 28, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share