DRKS00021684
Recruiting
Not Applicable
Evaluation and process optimization of the periinterventional setting for MRI-guided ablation of facet joints using high-intensity focused ultrasound (MR-HIFU).
Profound Medical GmbH 20457 Hamburg0 sites20 target enrollmentNovember 26, 2021
ConditionsM54.16
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- M54.16
- Sponsor
- Profound Medical GmbH 20457 Hamburg
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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