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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exablate treatment | Experimental | Exablate treatment on Neuropathic Pain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exablate treatment | Device | Exablate treatment for Neuropathic Pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro Neurolesi "Bonino-Pulejo" | Messina | 98124 | Italy |
sponsor
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |