Study of MRgFUS Exablate Treatment Following the Neuropathic Pain

InSightec

Status: Terminated

Conditions: Neuropathic Pain

Treatments: Device: Exablate treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04649554

NP003

Details and patient eligibility

About

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 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)

Enrollment: 2 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women age 30 years or older
• 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Experimental: ExAblate 4000 System

Experimental group

Description:

Exablate treatment on Neuropathic Pain

Treatment:

Device: Exablate treatment