RecruitingNot Applicable

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

United States, Japan60 participantsStarted 2023-01-23

Plain-language summary

This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

Who can participate

Age range30 Years – 99 Years

SexALL

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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.

What they're measuring

Responder Analysis

Timeframe: 5 years

Trial details

NCT IDNCT05539196

SponsorInSightec

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-07-31

Contact for this trial

Kingsley Nwaogu

2143048265 clinicalresearchquestions@insightec.com

View on ClinicalTrials.gov More Movement Disorders trials