MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:
HIFU-FACET
Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study
1 other identifier
interventional
10
1 country
1
Brief Summary
Patients suffering from facet-joint-syndrome associated with lower-back pain will be treated with MRI-guided High Intensity Focused Ultrasound thermal therapy for pain relief.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2022
CompletedFirst Submitted
Initial submission to the registry
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedSeptember 15, 2022
September 1, 2022
1.5 years
June 24, 2022
September 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility: planned temperature (57°C) achieved at target area of sonication
Temperatures achieved at the intended treatment location during MR-HIFU treatments
treatment day (4 hours)
Secondary Outcomes (4)
safety of entire procedure
180 days
Pain reduction after study treatment
180 days
change in Quality of Life (QoL) assessed via Quality of Life Questionnaire
180 days
comparison of contrast in MRI before and after treatment
180 days
Study Arms (1)
Treatment Arm
EXPERIMENTALThis is a single arm study
Interventions
Eligibility Criteria
You may qualify if:
- chronic low back pain
- clinical diagnosis of Lumbar Facet Joint Syndrome
- eligible for MRI and MR-HIFU session
- eligible for general anaesthesia
- intact skin and soft tissue over treatment zone
- facet joint anatomy clearly identifiable
- patients must be able to discontinue all pain relief medication for a minimum of 48 hours prior to baseline assessment
- patients able to provide consent for the study
You may not qualify if:
- spinal implants
- treatment target zone \< 10 mm from the skin
- pregnant female patients
- breastfeeding female patients
- body weight \> 140 kg
- systemic and/or local infections
- moderate to high grade of spinal instability
- MRI contrast agent contraindication
- any MRI-unsafe implant or pacemaker
- facet joint anatomy which is not targetable or reachable due to scars, surgical clips, implants, or prosthesis in the planned beam path of the ultrasound beam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Holger Gruell
Cologne, 50937, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Kourosh Zarghooni, PD
Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2022
First Posted
June 29, 2022
Study Start
June 10, 2022
Primary Completion
December 1, 2023
Study Completion
June 1, 2024
Last Updated
September 15, 2022
Record last verified: 2022-09