A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications

Launched by INSIGHTEC · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a specific treatment called Exablate for people with advanced Parkinson's disease who experience severe movement problems that don't respond well to medication. The trial aims to gather information about how effective and safe this treatment is over time. It involves about 60 participants from around 10 different medical centers around the world, who will be observed for up to five years after their treatment.

To be eligible for this trial, participants must be at least 30 years old and scheduled to receive the Exablate treatment for their Parkinson's disease. They need to agree to follow the study's requirements, including attending follow-up visits. Participants will have their progress checked at 3, 6, and 12 months after the procedure, and then once a year for the next five years. If someone does not want to take part in the study or is not likely to complete it, they won't be included. This trial will help better understand how this treatment can help those suffering from the challenges of Parkinson's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women, age 30 years and older.
• • Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.
• • Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits.
• • Subject has signed and received a copy of the approved informed consent form.
• Exclusion Criteria:
• • Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.