Registry to assess outcomes of the MagDI System for bowel surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to evaluate the incidence and severity of internal hernia and bowel obstruction in U.S. patients who undergo side-to-side duodeno-ileal anastomosis using the MagDI System. The study will collect data from participants treated at designated registry centers and compare these outcomes to previous clinical studies conducted outside the U.S. The focus is on understanding the effectiveness and safety of the MagDI System in a real-world setting, particularly in relation to complications such as bowel obstruction. Participants will be followed for one year post-surgery to gather comprehensive data on their health outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. \>21 years of age, at the time of informed consent.
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:

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

Where it's running

• Ventura Advanced Surgical Associates
  Ventura, California, United States Recruiting
• HCA Florida Mercy
  Miami, Florida, United States Recruiting
• Baptist Healthcare System, Inc.
  Louisville, Kentucky, United States Recruiting
• Ochsner Clinic Foundation
  Lafayette, Louisiana, United States Recruiting
• Bariatric Specialists of the Carolinas
  Cary, North Carolina, United States Recruiting
• Transform Weight Loss
  Lynnwood, Washington, United States Recruiting

Study contacts

• Study coordinator: Lisa Griffin Vincent, PhD, MA
• Email: clinical@gtmetabolic.com
• Phone: +1 763-200-1416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.