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NCT03884231 · ClinicalTrials.gov registry record
A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 74
- Enrollment target
NCT03884231: Completed study, sponsored by Abbott Medical Devices.
NCT03884231 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 74 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03884231 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 74 participants
- Enrollment target
Study Summary
The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.
Primary Outcome
Any adverse event that was included in the primary endpoint analysis, if it: 1. Was classified as being MRI-related (as determined by the CEC), occured during or after the MRI procedure, and cannot be attributed to any other cause; and 2. Was classified as being related to the device (implanted or external component) (as determined by the Investigator); and 3. Met the criteria for serious adverse event or was a non-serious adverse event that was the result of irrecoverable failure of therapy de
Interventions
- DEVICE Infinity DBS System with MR Conditional labelling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-04-10 |
| Est. Completion | 2021-08-20 |
What the finished NCT03884231 record still lists
NCT03884231 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 74 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Infinity DBS System with MR Conditional labelling is the first listed.
NCT03884231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03884231 about?
NCT03884231 is a clinical study titled "A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling". The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the appro...
What is the current status of trial NCT03884231?
This trial is currently completed. The enrollment target is 74 participants. The study started on 2019-04-10. Estimated completion is 2021-08-20.
What interventions are being tested in trial NCT03884231?
The interventions under investigation include: Infinity DBS System with MR Conditional labelling (DEVICE).
Who is sponsoring clinical trial NCT03884231?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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