Registry to assess outcomes of the MagDI System for bowel surgery
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)
GT Metabolic Solutions, Inc. · NCT06928545
This study is trying to see how well the MagDI System works for bowel surgery and if it causes fewer problems like internal hernias and blockages in patients in the U.S. compared to past studies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 106 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | GT Metabolic Solutions, Inc. (industry) |
| Locations | 5 sites (Ventura, California and 4 other locations) |
| Trial ID | NCT06928545 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults over 21 years old with a BMI between 30-50 who are indicated for a side-to-side duodeno-ileal anastomosis using the MagDI System.
Not a fit: Patients who do not meet the eligibility criteria or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of the MagDI System, potentially improving surgical outcomes for patients undergoing bowel surgery.
How similar studies have performed: While this study builds on previous findings regarding bowel obstruction, the specific use of the MagDI System in the U.S. population is novel and has not been extensively tested in similar observational settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ventura, California and 4 other locations
- Ventura Advanced Surgical Associates — Ventura, California, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anastomosis, Surgical, Internal Hernia, Bowel Obstruction, GT Metabolic, MagDI System, Magnetic Anastomosis