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Evaluation and process optimization of the periinterventional setting for MRI-guided ablation of facet joints using high-intensity focused ultrasound (MR-HIFU).

Evaluation and process optimization of the periinterventional setting for MRI-guided ablation of facet joints using high-intensity focused ultrasound (MR-HIFU).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021684
Enrollment
20
Registered
2021-11-26
Start date
2021-12-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M54.16

Interventions

Group 1: The ultrasound elements in the treatment table have only limited degrees of freedom, which means that only certain angles are possible and a defined area on the treatment table is technically

Sponsors

Profound Medical GmbH 20457 Hamburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion 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: 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactPatrick Schmidt

Universitätsklinikum Köln

patrick.schmidt@uk-koeln.de+4917699629266

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026