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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-99
SponsorInSightec

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.

Trial design

Treatments tested in this trial

  • Exablate Pallidotomy, Unilateral

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators