RecruitingNCT06928545

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)


Sponsor

GT Metabolic Solutions, Inc.

Enrollment

106 participants

Start Date

Mar 28, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 22 Years

Inclusion Criteria4

  • \>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.

Exclusion Criteria1

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

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Interventions

DEVICESide-to-side duodenal-ileal anastomosis

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


Locations(5)

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

Transform Weight Loss

Lynnwood, Washington, United States

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NCT06928545


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