NCT05802511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 15, 2023

Last Update Submit

March 27, 2023

Conditions

Peripheral NeuropathyNeuropathic Pain

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Exablate treatment

EXPERIMENTAL

Exablate treatment on Neuropathic Pain

Device: Exablate treatment

Interventions

Exablate treatmentDEVICE

Exablate treatment for Neuropathic Pain

Exablate treatment

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

Location

MeSH Terms

Conditions

Peripheral Nervous System DiseasesNeuralgia

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 6, 2023

Study Start

February 1, 2020

Primary Completion

February 15, 2021

Study Completion

February 28, 2021

Last Updated

April 6, 2023

Record last verified: 2023-03

Locations

IT(1)