NCT05539196 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
| NCT ID | NCT05539196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | InSightec |
| Condition | Movement Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-23 |
| Primary Completion | 2029-07-31 |
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 60 participants in total. It began in 2023-01-23 with a primary completion date of 2029-07-31.
⚠ 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
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05539196 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 99 Years, studying Movement Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05539196 currently recruiting?
Yes, NCT05539196 is actively recruiting participants. Contact the research team at clinicalresearchquestions@insightec.com for enrollment information.
Where is the NCT05539196 trial being conducted?
This trial is being conducted at Baltimore, United States, New York, United States, Philadelphia, United States, Dallas, United States and 1 additional location.
Who is sponsoring the NCT05539196 clinical trial?
NCT05539196 is sponsored by InSightec. The trial plans to enroll 60 participants.