Back to resultsMR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: (HIFU-FACET)
Primary Purpose
Facet Joint Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MR-HIFU
Sponsored by
About this trial
This is an interventional device feasibility trial for Facet Joint Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Holger GruellRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
This is a single arm study
Outcomes
Primary Outcome Measures
Feasibility: planned temperature (57°C) achieved at target area of sonication
Temperatures achieved at the intended treatment location during MR-HIFU treatments
Secondary Outcome Measures
safety of entire procedure
Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system
Pain reduction after study treatment
pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication
change in Quality of Life (QoL) assessed via Quality of Life Questionnaire
The change in QoL scores throughout study participation [as higher values, as better quality of Life]
comparison of contrast in MRI before and after treatment
Qualitative analysis of the change in image tissue contrast in MRI images taken prior, during and after the treatment. This is a visual evaluation only.
Full Information
NCT ID
NCT05436873
First Posted
June 24, 2022
Last Updated
September 14, 2022
Sponsor
Universitätsklinikum Köln
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT05436873
Brief Title
MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:
Acronym
HIFU-FACET
Official Title
Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Köln
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients with diagnosed facet-joint-syndrome are suffering from severe pain in the respective regions, mainly lower-back pain. Eligible patients will be treated with High Intensity Focused Ultrasound (HIFU) under MRI control. The control by MRI assures on the one hand the correct selection of area to be sonicated and monitors in parallel the temperature, reached in the target area. The aim is to thermally ablate facet joint and/or medial branch nerves at lumbar spine. Ablation is deemed to be feasible and successful if temperatures of at least 57°C are reached at the target. The entire procedure will be done under anaesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facet Joint Syndrome
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
There is only 1 treatment arm, as this is a feasibility study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
This is a single arm study
Intervention Type
Device
Intervention Name(s)
MR-HIFU
Intervention Description
MRI guided High Intensity Focused Ultrasound sonication.
Primary Outcome Measure Information:
Title
Feasibility: planned temperature (57°C) achieved at target area of sonication
Description
Temperatures achieved at the intended treatment location during MR-HIFU treatments
Time Frame
treatment day (4 hours)
Secondary Outcome Measure Information:
Title
safety of entire procedure
Description
Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system
Time Frame
180 days
Title
Pain reduction after study treatment
Description
pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication
Time Frame
180 days
Title
change in Quality of Life (QoL) assessed via Quality of Life Questionnaire
Description
The change in QoL scores throughout study participation [as higher values, as better quality of Life]
Time Frame
180 days
Title
comparison of contrast in MRI before and after treatment
Description
Qualitative analysis of the change in image tissue contrast in MRI images taken prior, during and after the treatment. This is a visual evaluation only.
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Krauss, PhD
Email
ChristianKrauss@uk-koeln.de
First Name & Middle Initial & Last Name or Official Title & Degree
Holger Gruell, Prof.
Phone
+49221
Ext
5880
Email
Holger.Gruell@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kourosh Zarghooni, PD
Organizational Affiliation
Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holger Gruell
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Gruell, Prof
First Name & Middle Initial & Last Name & Degree
Christian Krauss, PhD
Email
ChristianKrauss@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Kourosh Zarghooni, PD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:
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