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.
Summary
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.
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…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DeviceSide-to-side duodenal-ileal anastomosis
Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
Locations (5)
- Ventura Advanced Surgical AssociatesVentura, California
- Baptist Healthcare System, Inc.Louisville, Kentucky
- Ochsner Clinic FoundationLafayette, Louisiana
- Bariatric Specialists of the CarolinasCary, North Carolina
- Transform Weight LossLynnwood, Washington