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

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.

Study Overview

• Status: Recruiting
• Conditions: Facet Joint Syndrome
• Intervention / Treatment: Device: MR-HIFU

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Krauss, PhD; Email: ChristianKrauss@uk-koeln.de
• Study Contact Backup: Name: Holger Gruell, Prof.; Phone Number: 5880 +49221; Email: Holger.Gruell@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • Holger Gruell
    • Contact: Christian Krauss, PhD; Email: ChristianKrauss@uk-koeln.de
    • Contact: Holger Gruell, Prof
    • Principal Investigator: Kourosh Zarghooni, PD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; This is a single arm study	Device: MR-HIFU; MRI guided High Intensity Focused Ultrasound sonication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of entire procedure	Frequency and severity of adverse events associated with use of the Sonalleve MR-HIFU system	180 days
Pain reduction after study treatment	pain reduction as shown in VAS and change in frequency/type/dosing of pain relief medication	180 days
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]	180 days
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.	180 days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Kourosh Zarghooni, PD, Department of Orthopaedics and Trauma Surgery; Cologne University Hospital; Kerpener Strasse 62; D 50937 Cologne

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Uni-Koeln-4473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No