Peripheral NeuropathyNCT05802511
Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
A study testing Exablate treatment in people with Peripheral Neuropathy and Neuropathic Pain, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Peripheral Neuropathy, Neuropathic Pain
- What is being tested?
- Exablate treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Neuropathy, Neuropathic Pain
- Being tested
- Exablate treatment
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate treatmentDevice
Exablate treatment for Neuropathic Pain
| Study group | Role | What they receive |
|---|---|---|
| Exablate treatment | Experimental | Exablate treatment on Neuropathic Pain Receives: Device: Exablate treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Feb 2020
- Primary completion15 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802511
- Sponsor's protocol ID
- NP003
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: sponsor
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05802511
- Acronym / sponsor ID
- NP003
- Conditions
- Peripheral Neuropathy, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exablate treatment | Experimental | Device: Exablate treatmentExablate treatment on Neuropathic Pain |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exablate treatmentExablate treatment for Neuropathic Pain | Device | Exablate treatment |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Undecided. sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate treatment in people with Peripheral Neuropathy and Neuropathic Pain, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Score (NRS) (time frame: 72 h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.