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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; Peripheral Neuropathy
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98124
    • IRCCS Centro Neurolesi "Bonino-Pulejo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exablate treatment; Exablate treatment on Neuropathic Pain	Device: Exablate treatment; Exablate treatment for Neuropathic Pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Numerical Rating Score (NRS)	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.	72 h
Pain Numerical Rating Score (NRS)	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.	1 month
Pain Numerical Rating Score (NRS)	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.	3 months
Pain Numerical Rating Score (NRS)	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.	12 months

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: NP003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No