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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802511
• Other study ID #: NP003
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2023
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• Exablate treatment
Exablate treatment for Neuropathic Pain

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi "Bonino-Pulejo"	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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