N/A
N=74
A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling
Movement Disorders · Parkinson Disease · Essential Tremor · Tremor · Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT03884231 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Nov 2024
Primary outcome: Primary: Rate of MRI-related Adverse Events — 0 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Infinity DBS System with MR Conditional labelling (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of MRI-related Adverse Events |
— | — |
| SECONDARY Rate of Successful MRI Mode 'Turn on/Off' Functionality of the MRI Mode |
100 | — |
| SECONDARY Rate of Successful 'Turn on/Off' Functionality for the Stimulation |
100 | — |
| SECONDARY Rate of Successful Adjustments to the Stimulation Amplitude |
100 | — |
| SECONDARY Rate of Successful Interrogation and Download of the IPG Parameters |
100 | — |
| SECONDARY Rate of Successful Ability to Obtain Lead Impedance Measurements |
100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
- Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
- Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
- Subject is willing and able to comply with study requirements.
Exclusion Criteria
- Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
- Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
- Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
- Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Subject is currently participating in another clinical investigation that may confound the results of this study.
Data sourced from ClinicalTrials.gov (NCT03884231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.