Status:
UNKNOWN
Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Phantom Limb Pain
Residual Limbs
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
AIM: To provide initial information on the efficacy (pain reduction) and safety of focused ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic pain. PARTICIPANT...
Detailed Description
I. BACKGROUND: In 2005, 1.6 million people were estimated to be living with limb loss (3). Up to 70% of the patients who undergo limb amputation develop chronic phantom/residual limb pain. A state-of...
Eligibility Criteria
Inclusion
- Men and women amputees, aged 18 and older
- Patients who are able and willing to give consent and able to attend all study visits
- Patients who are suffering from post-amputation phantom/residual limb pain for at least 3 months
- Patient with average pain intensity on a 0-10 numerical pain scale (NPS) ≥ 4 during a 3 days period prior to enrollment irrespective of medication use
- Patient whose targeted (treated) lesion is deeper than 10-mm from the skin
- Targeted (treated) neuroma is clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
Exclusion
- Patients with any acute or unstable medical condition (e.g., infection, cardiac condition, uncontrolled diabetes mellitus, uncontrolled hypertension) that is expected to hinder them from completing this study
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight \>250 pounds (113kg), etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)
- Are participating or have participated in another clinical trial in the last 30 days
- Patients with persistent undistinguishable pain (pain source unidentifiable)
- Patients whose neuroma is \< 10-mm from the skin, blood vessels or bone
- Patients with more than three neuromas in the affected limb
- Targeted (treated) neuroma is NOT visible by non-contrast MRI
- Targeted neuroma is not accessible to ExAblate due to scar tissue or any other reason
Key Trial Info
Start Date :
April 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03255395
Start Date
April 24 2017
End Date
April 1 2019
Last Update
April 2 2019
Active Locations (1)
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1
Rambam Health Care Campus
Haifa, Israel