MagDI U.S. Registry

Launched by GT METABOLIC SOLUTIONS, INC. · Apr 8, 2025

Keywords

ClinConnect Summary

The MagDI U.S. Registry is a clinical trial that aims to study how often and how severe internal hernias and bowel obstructions occur in patients one year after using a new device called the MagDI System. This device is used to help connect two parts of the intestine (the duodenum and ileum) in a specific way. The trial is currently looking for participants across the United States who are over 21 years old, have a body weight that falls within a certain range (BMI of 30-50), and are scheduled to undergo this type of surgery using the MagDI System.

If you join this study, you will be monitored for one year to see how you are doing after the surgery. The main goal is to gather information that can help improve patient care and outcomes for others undergoing similar procedures. It’s essential that participants understand what the study involves and provide their consent to be part of it. This trial is open to everyone, regardless of gender, as long as they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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.