Status:
RECRUITING
MagDI U.S. Registry
Lead Sponsor:
GT Metabolic Solutions, Inc.
Conditions:
Anastomosis, Surgical
Internal Hernia
Eligibility:
All Genders
22+ years
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 litera...
Eligibility Criteria
Inclusion
- \>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
- 1\. Participant does not provide informed consent to be enrolled and followed in the registry.
Key Trial Info
Start Date :
March 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06928545
Start Date
March 28 2025
End Date
April 1 2027
Last Update
December 31 2025
Active Locations (4)
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1
Ventura Advanced Surgical Associates
Ventura, California, United States, 93003
2
Baptist Healthcare System, Inc.
Louisville, Kentucky, United States, 40299
3
Ochsner Clinic Foundation
Lafayette, Louisiana, United States, 70503
4
Bariatric Specialists of the Carolinas
Cary, North Carolina, United States, 27518