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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 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 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 5 states.

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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.

Conditions Studied

Parkinson's Disease Movement Disorders Neurology

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

FieldValue
Enrollment Target 60 participants
Start Date 2023-01-23
Est. Completion 2029-07-31

Sponsor

InSightec

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05539196

The ClinicalTrials.gov registry entry for NCT05539196 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (91% lower). The listed sponsor is InSightec, which has 38 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.