MagDI U.S. Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorGT Metabolic Solutions, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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.
Disqualifiers
None
Trial population
All eligible patients in the U.S. who undergo a side-to-side duodeno-ileal anastomosis with the MagDI System.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Side-to-side duodenal-ileal anastomosis
DeviceSide-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.
Treatment groups
106 Participants
are divided into 1 treatment groupGroup A: MagDI System1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Internal Hernia and Bowel Obstructions
To assess and characterize incidence and severity of internal hernia and bowel obstruction at one year in U.S. patients treated with the MagDI System compared with the pre-market study (GTM-001) and scientific literature.
Time frame
From date of study index procedure through 360 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov