Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
NCT ID: NCT05802511
Last Updated: 2023-04-06
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-02-01
2021-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Exablate treatment
Exablate treatment on Neuropathic Pain
Exablate treatment
Exablate treatment for Neuropathic Pain
Interventions
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Exablate treatment
Exablate treatment for Neuropathic Pain
Eligibility Criteria
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Inclusion Criteria
* Subject undergoing an Exablate procedure for their planned neuropathic treatment per local institution standard of care
* 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)
* 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
* Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
* Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
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
55 Years
ALL
No
Sponsors
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IRCCS Centro Neurolesi Bonino Pulejo
OTHER
Responsible Party
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Locations
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IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, , Italy
Countries
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Other Identifiers
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NP003
Identifier Type: -
Identifier Source: org_study_id
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