Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status

Completed

Conditions

Peripheral Neuropathy

Neuropathic Pain

Treatments

Device: Exablate treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05802511

NP003

Details and patient eligibility

About

The Exablate 4000 obtained CE Mark for the treatment of Neuropathic Pain in December 2012. The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for 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.

Full description

The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.

Enrollment

30 patients

Sex

All

Ages

30 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women age 30 years or older
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 diagnosed with a nociceptive chronic pain syndrome
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