Evaluation and process optimization of the periinterventional setting for MRI-guided ablation of facet joints using high-intensity focused ultrasound (MR-HIFU).
Recruiting
- Conditions
- M54.16
- Registration Number
- DRKS00021684
- Lead Sponsor
- Profound Medical GmbH 20457 Hamburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Presence of back pain in the subjects is possible in principle. However, since the correlation between image morphological findings in the MRI and symptoms is low, this is not defined as a necessary inclusion criterion.
Exclusion Criteria
Exclusion criteria for the study are the usual contraindications for performing an MRI examination (patients with pacemakers, neurostimulators, implanted pump systems, ferromagnetic implants). The examination is performed in native technique, therefore the exclusion criteria for MRI contrast agents do not apply. Furthermore, pregnant subjects or patients as well as persons with claustrophobia are excluded. In addition, the participation of subjects with previous lumbar spine surgery is excluded.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This is a scientific, monocentric study to optimize the positioning, image quality and sequence protocol for a subsequent study on the treatment of facet joints using HIFU. Here, the acoustic access path will be optimized by preparatory measures and positioning maneuvers, and the coil that has the best imaging properties will be selected. The results are to be the basis for a scientific publication, as well as enabling the further planned treatments of patients with back pain within the framework of the funding program of the Federal Ministry of Education and Research.
- Secondary Outcome Measures
Name Time Method