RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-23
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05539196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women, age 30 years and older.
  2. * Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.
  3. * Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits.
  4. * Subject has signed and received a copy of the approved informed consent form.
  1. * Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.

Contacts and Locations

Study Contact

Nadir Alikacem
CONTACT
+12146302000
nadira@insightec.com
Gaganjot Sooch
CONTACT
+12146302000
gaganjot@insightec.com

Study Locations (Sites)

University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States
Weill Cornell Medicine
New York, New York, 10065
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: InSightec

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-23
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2023-01-23
Study Completion Date2029-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Movement Disorders
  • Neurology
  • Parkinsons Disease