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
InSightec
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.
Description
This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects participating in this registry will have received a unilateral pallidotomy using the commercially available Exablate Neuro. The following assessments will be collected at Baseline, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years: Adverse Events (AEs)…
Eligibility
- Age range
- 30–99 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DeviceExablate Pallidotomy, Unilateral
Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.
Locations (5)
- University of Maryland, BaltimoreBaltimore, Maryland
- Weill Cornell MedicineNew York, New York
- University of PennsylvaniaPhiladelphia, Pennsylvania
- University of Texas Southwestern Medical CenterDallas, Texas
- Ohnishi Neurological CenterAkashi, Hyōgo