Trials / Completed
CompletedNCT03884231
A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 74 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Infinity DBS System with MR Conditional labelling | Patients implanted with the Infinity DBS system with MR Conditional labeling |
Timeline
- Start date
- 2019-04-10
- Primary completion
- 2021-07-22
- Completion
- 2021-08-20
- First posted
- 2019-03-21
- Last updated
- 2024-11-20
- Results posted
- 2024-11-20
Locations
16 sites across 5 countries: United States, France, Germany, Spain, Sweden
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03884231. Inclusion in this directory is not an endorsement.