DRKS00029279
Recruiting
Phase 2
Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study - HIFU-FACET
niversitätsklinikum Köln0 sites10 target enrollmentJune 21, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- M47.9
- Sponsor
- niversitätsklinikum Köln
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female, \> 18 years old
- •a. Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 7 days prior to MR\-HIFU treatment
- •b. and must agree to use effective contraceptive birth control measures (Pearl Index \< 1\) during the course of the trial. A female patient is considered to be of childbearing potential unless she is above 50 years of age and naturally amenorrhoeic for \= 2 years, or unless she is surgically sterile.
- •2\. Patients with chronic LBP refractory to medical and/or physical treatment.
- •3\. Clinical diagnosis of Lumbar Facet Joint Syndrome (radiologic signs of facet joint osteoarthritis and/or positive diagnostic infiltration of suspected facet joint levels)
- •4\. Eligibility for MR imaging and MR\-HIFU sessions
- •5\. Eligibility for general anesthesia and/or sedation
- •6\. Intact skin and soft tissue over treatment zone
- •7\. Facet Joint Anatomy clearly identifiable, targetable, and reachable in MRI for treatment
- •8\. Patients able to discontinue all current analgesic medications for a minimum 48\-hour (or \=5 half\-lives of the particular analgesic, whichever is greater) prior to baseline assessment.
Exclusion Criteria
- •Exclusion Criteria
- •1\. Spinal implants
- •2\. Treatment target zone \< 10mm from the skin
- •3\. Pregnant female patients
- •4\. Breastfeeding female patients
- •5\. Body weight \> 140 kg
- •6\. Systemic and/or local infections
- •7\. Moderate to high grade of spinal instability (Grade II – IV)
- •8\. MRI contrast agent contraindications
- •9\. Any MR\-unsafe implant or pacemaker. Any MR\-conditional implant that requires scanning with less than 3 Tesla or adjustments to the scan protocol.
Outcomes
Primary Outcomes
Not specified
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