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NCT Number: NCT05802511

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.

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Key information

Conditions

Peripheral Neuropathy Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exablate treatment

Device

Exablate treatment for Neuropathic Pain

Primary outcomes

  1. Pain Numerical Rating Score (NRS)

    Time frame: 72 h

    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.

  2. Pain Numerical Rating Score (NRS)

    Time frame: 1 month

    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. Pain Numerical Rating Score (NRS)

    Time frame: 3 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.

  4. Pain Numerical Rating Score (NRS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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