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

Parkinson Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

This is a study of subjects with the St. Jude Medical Infinity deep brain stimulation (DBS) system who undergo an MRI imaging procedure. Enrollment may occur before DBS implant, or when an MRI scan is planned in a subject with an existing implant. There will be a follow-up visit one month after the MRI procedure to document any adverse events and verify device functionality.

Clinical Trial Description

This study will be conducted as an international, multicenter,observational, prospective, single-arm, post-market clinical follow-up (PMCF). The study will evaluate the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure is performed according to the approved guidance.

The study will enroll approximately 74 subjects at up to 25 centers in geographies where Infinity DBS systems with MR Conditional labeling is approved, including the European Union and the United States. Subjects who have a leads-only configuration or a full system configuration will participate in the study. Subjects may be enrolled when an MRI procedure is prescribed per standard of care.

Each subject will be limited to one MRI procedure during the course of the study. Data collected include MRI parameters and any adverse events that occur during or after the procedure. There will be an office visit to document any adverse events and verify device functionality for all subjects one month (30 days ± 14 days) post-MRI follow-up visit after the initial MRI procedure is performed. ;

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Movement Disorders
• Parkinson Disease
• Tremor

• NCT number: NCT03884231
• Study type: Observational
• Source: Abbott Medical Devices
• Status: Completed
• Start date: April 10, 2019
• Completion date: August 20, 2021