Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT03255395
Eligibility Criteria:
Inclusion Criteria:
1. Men and women amputees, aged 18 and older
2. Patients who are able and willing to give consent and able to attend all study visits
3. Patients who are suffering from post-amputation phantom/residual limb pain for at least 3 months
4. 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
5. Patient whose targeted (treated) lesion is deeper than 10-mm from the skin
6. Targeted (treated) neuroma is clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
Exclusion Criteria:
1. 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
2. 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.
3. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
4. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)
5. Are participating or have participated in another clinical trial in the last 30 days
6. Patients with persistent undistinguishable pain (pain source unidentifiable)
7. Patients whose neuroma is \< 10-mm from the skin, blood vessels or bone
8. Patients with more than three neuromas in the affected limb
9. Targeted (treated) neuroma is NOT visible by non-contrast MRI
10. Targeted neuroma is not accessible to ExAblate due to scar tissue or any other reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03255395
Study Brief:
Protocol Section:
NCT03255395