Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
106 participants
OBSERVATIONAL
2025-03-28
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MagDI System
Participants who underwent the MagDI System procedure and consented to participate in the Registry
Side-to-side duodenal-ileal anastomosis
Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
Interventions
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Side-to-side duodenal-ileal anastomosis
Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
Eligibility Criteria
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Inclusion Criteria
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
22 Years
ALL
No
Sponsors
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GT Metabolic Solutions, Inc.
INDUSTRY
Responsible Party
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Locations
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Ventura Advanced Surgical Associates
Ventura, California, United States
Baptist Healthcare System, Inc.
Louisville, Kentucky, United States
Ochsner Clinic Foundation
Lafayette, Louisiana, United States
Bariatric Specialists of the Carolinas
Cary, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Hellmuth Billy
Role: primary
Candice Brunton
Role: primary
Ashunti Pearson
Role: primary
Jamie Lee Bull, PA
Role: primary
Other Identifiers
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GTM-007
Identifier Type: -
Identifier Source: org_study_id