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A Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.
The objectives of this study are to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment and to capture safety data of the procedure. The safety assessment measure is the incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment. Performance will be measure by assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the Numeric Rating Scale (NRS)
Age
30 - No limit years
Sex
ALL
Healthy Volunteers
No
Fondazione IRCCS Neurologico Carlo Besta
Milan, Italy
Start Date
October 8, 2020
Primary Completion Date
December 31, 2021
Completion Date
August 3, 2023
Last Updated
March 20, 2026
2
ACTUAL participants
Exablate treatment
DEVICE
Lead Sponsor
InSightec
NCT07436806
NCT06726954
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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