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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
InSightec
Study ID
NCT05539196
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Exablate Pallidotomy, Unilateral — DEVICE
    Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.

Study Details

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.

Key Dates

Start date
Jan 23, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Responder Analysis [ Time Frame: 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201
Kaitlyn Henry
[email protected]
410-328-0939
Howard Eisenberg, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Rachel Olovyannikov
[email protected]
(212) 746-7373
Isabella Cipollone
[email protected]
(203) 917-9918
Michael Kaplitt, MD PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19106
Giovanna Rocchio
[email protected]
215-829-6720
Casey Halpern, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Claire Starcke
[email protected]
214-645-1568
Bhavya Shah, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Maryland, Baltimore· Baltimore, MDWeill Cornell Medicine· New York, NYUniversity of Pennsylvania· Philadelphia, PAUniversity of Texas Southwestern Medical Center· Dallas, TX

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