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A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

NCT03884231 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2024-11-20

Study results available
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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

DEVICE

Infinity DBS System with MR Conditional labelling

Patients implanted with the Infinity DBS system with MR Conditional labeling

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Binith Cheeran · Abbott Medical Devices Neuromodulation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2021-07-22
Completion
2021-08-20
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Spain
  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03884231 on ClinicalTrials.gov