A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
Public ClinicalTrials.gov record NCT03884231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03884231
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 74 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 10, 2019 (Actual)
- Primary completion
- Jul 22, 2021 (Actual)
- Completion
- Aug 20, 2021 (Actual)
- Last update posted
- Nov 20, 2024
2019 – 2021
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center Tucson Campus | Tucson | Arizona | 85724 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Neurosurgery One | Littleton | Colorado | 80122 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Willis-Knighton Medical Center | Shreveport | Louisiana | 71103 | — |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | — |
| Wright State University & Premier Health | Fairborn | Ohio | 45324 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Inland Northwest Research | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03884231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03884231 live on ClinicalTrials.gov.