About this trial

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 criteria

Qualifiers

>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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Side-to-side duodenal-ileal anastomosis

Treatment groups

106 Participants
are divided into 1 treatment group

Locations

5
Ventura Advanced Surgical Associates93003, VenturaCalifornia, United States
Baptist Healthcare System, Inc.40299, LouisvilleKentucky, United States
Ochsner Clinic Foundation70503, LafayetteLouisiana, United States
Bariatric Specialists of the Carolinas27518, CaryNorth Carolina, United States

Sponsors and collaborators

GT Metabolic Solutions, Inc.

Lead sponsor