NCT04991831 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
| NCT ID | NCT04991831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | InSightec |
| Condition | Tremor Associated With Tremor Dominant Parkinson's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-04-28 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-04-28 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Men and women, age 30 years and older 2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care. 3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits 4. 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 study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04991831 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 99 Years, studying Tremor Associated With Tremor Dominant Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04991831 currently recruiting?
Yes, NCT04991831 is actively recruiting participants. Contact the research team at clinicalresearchquestions@insightec.com for enrollment information.
Where is the NCT04991831 trial being conducted?
This trial is being conducted at Miami, United States, Chicago, United States, Boston, United States, New York, United States and 4 additional locations.
Who is sponsoring the NCT04991831 clinical trial?
NCT04991831 is sponsored by InSightec. The trial plans to enroll 50 participants.
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