MagDI U.S. Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Side-to-side duodenal-ileal anastomosis.
- Who it may be relevant to
- Registry conditions: Anastomosis, Surgical, Internal Hernia, Bowel Obstruction. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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 literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).
Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.
Interventions
- Device Side-to-side duodenal-ileal anastomosis
Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
Primary outcome measures
- Incidence of Internal Hernia and Bowel Obstructions [Time frame: From date of study index procedure through 360 days.]
Eligibility criteria
Inclusion criteria
- >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 criteria
1\. Participant does not provide informed consent to be enrolled and followed in the registry.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- Ventura Advanced Surgical Associates — Ventura
- Baptist Healthcare System, Inc. — Louisville
- Ochsner Clinic Foundation — Lafayette
- Bariatric Specialists of the Carolinas — Cary
- Transform Weight Loss — Lynnwood
Identifiers
NCT: NCT06928545 · GTM-007