Recruiting

Exablate 4000A 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

Sponsor:

InSightec

Code:

NCT05539196

Conditions

Movement Disorders

Neurology

Parkinsons Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Exablate Pallidotomy, Unilateral

Study Details

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.

Conditions

Movement Disorders

Neurology

Parkinsons Disease

Study ID

NCT05539196

Start date

Jan 23, 2023

Status verified date

Mar, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Exablate Pallidotomy, Unilateral

Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.

Primary outcome measure

Responder Analysis [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Kingsley Nwaogu

2143048265 clinicalresearchquestions@insightec.com

Julia Zhu

2148462577 clinicalresearchquestions@insightec.com

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kaitlyn Henry

410-328-0939 KHenry@som.umaryland.edu

Principal Investigator:

Howard Eisenberg, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Rachel Olovyannikov

(212) 746-7373 rao4005@med.cornell.edu

Isabella Cipollone

(203) 917-9918 isc4005@med.cornell.edu

Principal Investigator:

Michael Kaplitt, MD PhD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19106

Contacts

Giovanna Rocchio

215-829-6720 NPN@uphs.upenn.edu

Principal Investigator:

Casey Halpern, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Claire Starcke

214-645-1568 Charlton.Starcke@UTSouthwestern.edu

Principal Investigator:

Bhavya Shah, MD

More Information

Sponsor

InSightec

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by InSightec on 2026-03-20.