Study of MRgFUS Exablate Treatment Following the Neuropathic Pain
NCT ID: NCT04649554
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2020-10-08
2023-08-03
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: ExAblate 4000 System
Exablate treatment on Neuropathic Pain
Exablate treatment
Ablation
Interventions
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Exablate treatment
Ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG)
* Patient has a score of 6 or higher on the Numeric Rating Scale (NRS)
* Evidence that the subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes
* Evidence that the subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
Exclusion Criteria
* Subject does not agree to participate or is unlikely to participate for the entirety of the study
* Subject is currently participating in another clinical investigation with an active treatment arm
30 Years
ALL
No
Sponsors
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InSightec
INDUSTRY
Responsible Party
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Principal Investigators
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Patrice Horwath
Role: STUDY_DIRECTOR
InSightec
Locations
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Fondazione IRCCS Neurologico Carlo Besta
Milan, , Italy
Countries
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Other Identifiers
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NP003
Identifier Type: -
Identifier Source: org_study_id