NCT05436873

MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome:

Evaluation of Sonalleve MR-HIFU for Non-invasive Thermal Therapy of Facet-Joint Syndrome: Feasibility and Safety Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Universitätsklinikum Köln · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Facet Joint Syndrome

Interventions

Type	Name	Description
DEVICE	MR-HIFU	MRI guided High Intensity Focused Ultrasound sonication.

Timeline

• Start date: 2022-06-10
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2022-06-29
• Last updated: 2022-09-15

Locations

1 site across 1 country: Germany