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

Primary Purpose

Peripheral Neuropathy, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Exablate treatment
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exablate treatment

Arm Description

Exablate treatment on Neuropathic Pain

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 27, 2023
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT05802511
Brief Title
Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
Official Title
Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exablate treatment
Arm Type
Experimental
Arm Description
Exablate treatment on Neuropathic Pain
Intervention Type
Device
Intervention Name(s)
Exablate treatment
Intervention Description
Exablate treatment for Neuropathic Pain
Primary Outcome Measure Information:
Title
Pain Numerical Rating Score (NRS)
Description
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.
Time Frame
72 h
Title
Pain Numerical Rating Score (NRS)
Description
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.
Time Frame
1 month
Title
Pain Numerical Rating Score (NRS)
Description
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.
Time Frame
3 months
Title
Pain Numerical Rating Score (NRS)
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IRCCS Centro Neurolesi "Bonino-Pulejo"
City
Messina
ZIP/Postal Code
98124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
sponsor

Learn more about this trial

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

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