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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.
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) (does not apply to Baseline Visit) Medication usage MDS-UPDRS Unified Dyskinesia Rating Scale EQ-5D-5L WPAI-GH Clinician and Patient Global Impression of Change Patient Satisfaction Questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post Exablate Neuro Pallidotomy for Parkinson's Disease with Motor Complications | The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson's disease with medication-refractory moderate to severe motor complications. No intervention is performed under this registry protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exablate Pallidotomy, Unilateral | Device | Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Analysis | Primary Effectiveness will be evaluated through a Responder analysis. Responder is defined as the patient reaching a minimally clinically significant difference on: 1) UDysRS Objective Assessment ON Meds, without clinically significant worsening of MDS-UPDRS Part III OFF Meds aggregated extremity score for treated side Or 2) MDS-UPDRS Part III OFF Meds Motor Exam on the treated side, without clinically significant worsening of UDysRS Objective Assessment ON meds | 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Analysis | Safety will be evaluated through descriptive analysis of the incidence and severity of adverse events. Adverse events will be recorded and categorized according to severity, expectedness, and relationship to Exablate Neuro system pallidotomy procedure and/or disease progression. | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson's disease with medication-refractory moderate to severe motor complications. Subjects must meet the specific eligibility criteria in order to enroll in this Registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kingsley Nwaogu | Contact | 2143048265 | clinicalresearchquestions@insightec.com | |
| Julia Zhu | Contact | 2148462577 | clinicalresearchquestions@insightec.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19106 | United States |
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| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| Ohnishi Neurological Center | Recruiting | Akashi | Hyōgo | 674-0064 | Japan |
|
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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