RecruitingNot Applicable

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

United States50 participantsStarted 2022-04-28

Plain-language summary

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

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 an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
✓. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
✓. Subject has signed and received a copy of the approved informed consent form

What they're measuring

Long-term adverse events.

Timeframe: Five years.

Trial details

NCT IDNCT04991831

SponsorInSightec

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Matt Hibert

214-630-2000 clinicalresearchquestions@insightec.com

View on ClinicalTrials.gov More Tremor Associated With Tremor Dominant Parkinson's Disease trials