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NCT05539196 · ClinicalTrials.gov registry record
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
A clinical trial of Parkinson's Disease and Movement Disorders, sponsored by InSightec.
- Recruiting
- Registry status
- 60
- Enrollment target
- 5
- Study locations
NCT05539196: Recruiting study of Parkinson's Disease and Movement Disorders, sponsored by InSightec.
NCT05539196 is a study of Parkinson's Disease and Movement Disorders that is actively recruiting participants, run by InSightec. The registered enrollment target is 60 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05539196, a study of Parkinson's Disease and Movement Disorders, is actively recruiting participants, sponsored by InSightec.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Exablate Pallidotomy, Unilateral
Study Locations (5)
Maryland
- University of Maryland, Baltimore - Baltimore
New York
- Weill Cornell Medicine - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
Texas
- University of Texas Southwestern Medical Center - Dallas
Hyōgo
- Ohnishi Neurological Center - Akashi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2029-07-31 |
What NCT05539196 shows while recruiting
NCT05539196 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Exablate Pallidotomy, Unilateral is the first listed.
NCT05539196 lists 5 locations in 5 states (Maryland, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05539196 about?
NCT05539196 is a clinical study titled "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". 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.
What is the current status of trial NCT05539196?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2023-01-23. Estimated completion is 2029-07-31.
What conditions does trial NCT05539196 study?
This clinical trial studies the following conditions: Parkinson's Disease, Movement Disorders, Neurology.
What interventions are being tested in trial NCT05539196?
The interventions under investigation include: Exablate Pallidotomy, Unilateral (DEVICE).
Who is sponsoring clinical trial NCT05539196?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05539196 being conducted?
This trial has 5 study locations across Maryland, New York, Pennsylvania, Texas, Hyōgo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05539196's enrollment target sits among peer trials
60 76th of 158 higher than 82 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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