Study of MRgFUS Exablate Treatment Following the Neuropathic Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuropathic Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 125 years
- Gender
- Both males and females
Description
The objectives of this study are to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment and to capture safety data of the procedure. The safety assessment measure is the incidence and freque...
The objectives of this study are to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment and to capture safety data of the procedure. The safety assessment measure is the incidence and frequency of device and procedure related Adverse Events (AEs) in subjects who undergo an Exablate treatment. Performance will be measure by assessing the change from baseline to 3 months post Exablate treatment for pain intensity defined as a decrease of at least 30% of pain on the Numeric Rating Scale (NRS). Assessing the change from baseline to 6-12 months post Exablate treatment for pain intensity assessed by using the Numeric Rating Scale (NRS)
Tracking Information
- NCT #
- NCT04649554
- Collaborators
- Not Provided
- Investigators
- Study Director: Patrice Horwath InSightec
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