|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P150038 S006/ PAS001 |
| Date Original Protocol Accepted |
11/06/2020
|
| Date Current Protocol Accepted |
11/11/2022
|
| Study Name |
PAS Registry Study for ExAblate 4000
|
| Device Name |
ExAblate
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, multicenter, international single arm, observational post-approval registry study
|
| Study Population |
Single-arm study of male and female patients at least 30 years old who plan to be treated for TDPD using the Exablate Neuro System and who meet the specific enrollment criteria
|
| Sample Size |
50 patients are planned for this registry study. From the protocol:
A total of 50 subjects will be enrolled. A t-test graph demonstrated that the power will be sufficient to determine any significant differences in long-term effectiveness at a=0.05. The graph showed that at 25 subjects, the number of subjects needed had plateaued. With an approximate average of an 8% dropout per year through Year 5, the remaining population is estimated to be approximately 30 subjects at year 5, which shows full power.
|
| Key Study Endpoints |
From the protocol:
Safety Analysis
Safety will be evaluated through descriptive analysis of the incidence and severity of adverse events. Adverse events will be recorded and categorized according to severity, expectedness, and relationship to Exablate Neuro system thalamotomy procedure and/or disease progression. Results will be tabulated and reported as follows:
Post thalamotomy incidence and severity of adverse events (AEs).
Comparison of post thalamotomy incidence and severity adverse event rates to the prior Exablate study for ET (PMA #P150038), and TDPD earlier study (P150038/S006).
Comparison of post thalamotomy incidence and severity adverse
events rates to prior Deep Brain Stimulation (DBS) rates
Effectiveness Analysis
Effectiveness will be evaluated through descriptive analysis of ON medication CRST scores for tremor/motor, posture/rest, and level of
disability. Results will be presented as percent change from baseline to post thalamotomy study visits for all subjects where unilateral Exablate
thalamotomy was attempted.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
There are 10 events in six of the 10 subjects. Four subjects had no adverse events (total subjects, 10). Three of the events were new this reporting period (arm pain and upper respiratory tract infection, both of which were Unrelated, and dyskinesia related to the thalamotomy procedure). Four events in three subjects were Mild in severity, three events were Moderate, three events in two subjects were Severe, all of which were reported in the previous semiannual report, and no events were Life Threatening. There were no new Severe AEs in this reporting period. Six out of 10 adverse events were either transient, resolving within three days or unrelated to the device or procedure. Three events were Thalamotomy related. The event of severe imbalance issues was reported five days post treatment and was reported in the previous semiannual report.
Effectiveness Results
The 10 treated subjects have just begun the follow up phase of the registry and data entry is ongoing. As noted above one subject did not achieve effective energy delivery for ablation. This subject is being followed for safety only.
|
| Actual Number of Patients Enrolled |
10
|
| Actual Number of Sites Enrolled |
7
|
| Patient Follow-up Rate |
There have been three missed visits, two in one subject, however, these subjects remain in the study
|
