MagDI U.S. Registry

GT Metabolic Solutions

Status: Enrolling

Conditions: Anastomosis, Surgical; Bowel Obstruction; Internal Hernia

Treatments: Device: Side-to-side duodenal-ileal anastomosis

Study type: Observational

Funder types: Industry

Identifiers

NCT06928545

GTM-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

106 participants in 1 patient group

MagDI System

Description:

Participants who underwent the MagDI System procedure and consented to participate in the Registry

Treatment:

Device: Side-to-side duodenal-ileal anastomosis