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

Not Applicable

Completed

• Conditions: Peripheral Neuropathy; Neuropathic Pain
• Interventions: Device: Exablate treatment

• Registration Number: NCT05802511
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-28
• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exablate treatment	Exablate treatment	Exablate treatment on Neuropathic Pain

Primary Outcome Measures

Name	Time	Method
Pain Numerical Rating Score (NRS)	12 months	The pain NRS consists of 1 question that will be asked by interviewing the subjects. The subjects will be asked to rate their average pain over the past 24 hours specific to the area(s) of the pain being treated on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.

Trial Locations

Locations (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"; 🇮🇹 Messina, Italy