CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
Infinity DBS System with MR Conditional labellingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03884231
NCT03884231N/ACompleted
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A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

Abbott Medical Devices·observational·Posted Mar 21, 2019·Updated Nov 20, 2024

In Brief

An observational study evaluating Infinity DBS System with MR Conditional labelling for Movement Disorders and 4 related conditions. Completed, enrolled 74 participants across 16 sites in 5 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMovement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia
CountriesFrance, Germany, Spain, Sweden, United States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartApr 10, 2019
Primary CompletionJul 22, 2021
Study CompletionAug 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.3 years ago

Interventions

Infinity DBS System with MR Conditional labellingdevice

Patients implanted with the Infinity DBS system with MR Conditional labeling