- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07647757
Neurolyser XR for the Treatment of Sacroiliitis
12 de junio de 2026 actualizado por: Pasquale Buonanno, Federico II University
Safety and Efficacy of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain
Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis.
Sacroiliitis is the inflammation of a joint in the lowest part of the spin and it is one of the cause of low back; the diagnosis is essentially based on clinical examination and the confirmation of this diagnosis relies on a significant pain relief following an infiltration of local anesthetic in the joint.
One of the potential treatment is to ablate the nerves which carry the painful stimuli from the joint to the central nervous system through; these nerves enter the spinal canal through the sacral foramina which are two series of four pairs of openings located on the sacrum, the triangular bone at the base of the spine.
Traditionally, these nerves are ablated by the heat produced by radiofrequency or the cold produced by cryoablation; both techniques require percutaneous needle insertion in close proximity to the targeted nerves, posing potential discomfort and risk of infection for the patient.
High intensity focused ultrasound delivered by the device Neurolyser XR uses ultrasounds which are converged to the targeted point thanks to a gel pad positioned on the back of the patient; this mechanism of action does not require sterile conditions as the skin is not pierced and the discomfort of patient is dramatically reduced during the procedure for there is non need to insert and move any needle to properly position it.
The correct orientation of the ultrasound beam is guaranteed by the alignment of the targeting system of the device and the X-ray image.
The lesion is produced only if there is a bone right under the focus of the ultrasound beam and this is a safety system which assures that no direct injuries of other structures (e.g., vessels, spinal root) can be caused.
To date, Neurolyser XR has been extensively used to treat facet joint syndrome through the ablation of the medial branches.
However, its application in sacroiliitis has not yet been as deeply investigated.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Pasquale Buonanno, Professor
- Número de teléfono: +39 081 7463705
- Correo electrónico: pasquale.buonanno@unina.it
Ubicaciones de estudio
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Naples, Italia, 80131
- Department of Neuroscience, Reproductive and Odontostomatological Sciences
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Contacto:
- Pasquale Buonanno, Professor
- Número de teléfono: +390817463705
- Correo electrónico: pasquale.buonanno@unina.it
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adult males and females, legally able and willing to participate in the study and come for follow-up visits
- Able and willing to fill the research questionnaires and to communicate with investigator and research team
- Patient with bilateral or unilateral sacroiliac joint pain of > 6 months duration
- Patients presenting with a) a positive (>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
- Average pain score of 4 or higher in the last month, (on 0-10 scale).
Exclusion Criteria:
- Pregnant or breastfeeding patient
- Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
- Patients with history of lumbar and / or sacral spine surgery
- Patients with the presence of metal hardware at the lumbosacral spine
- Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study principal investigator)
- Patients unable to understand and complete the research questionnaires in Italian.
- Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
- Patient with extensive scarring in the skin and tissue overlying the treatment area.
- Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: HIFU patients
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Patients in this group will be treated with high intensity focused ultrasound; they will be placed in a prone position and through radiographic guidance, the targeting system of the device will be sequentially positioned in 6-8 points along a line between sacral foramina and sacroiliac joint to produce as many lesions.
Before any ablation, a 20 second stimulation at low energy will be performed to confirm the right position of the ultrasound focus than a higher intensity stimulation will be applied to perform the ablation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain intensity
Periodo de tiempo: From the enrollment to the end of 6 month follow-up
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Numeric rating scale (NRS): the patient has to assign a number from 0 (no pain) to 10 (worst possible pain) to his pain
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From the enrollment to the end of 6 month follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Gofeld M, Smith KJ, Bhatia A, Djuric V, Leblang S, Rebhun N, Aginsky R, Miller E, Skoglind B, Hananel A. Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study. Reg Anesth Pain Med. 2025 Jun 10;50(6):464-470. doi: 10.1136/rapm-2024-105345.
- Gofeld M, Tiennot T, Miller E, Rebhun N, Mobley S, Leblang S, Aginsky R, Hananel A, Aubry JF. Fluoroscopy-guided high-intensity focused ultrasound ablation of the lumbar medial branch nerves: dose escalation study and comparison with radiofrequency ablation in a porcine model. Reg Anesth Pain Med. 2025 May 6;50(5):429-436. doi: 10.1136/rapm-2024-105417.
- Aginsky R, LeBlang S, Hananel A, Chen J, Gofeld M, Perez J, Shir Y, Aubry JF. Tolerability and Feasibility of X-ray Guided Non-Invasive Ablation of the Medial Branch Nerve with Focused Ultrasound: Preliminary Proof of Concept in a Pre-clinical Model. Ultrasound Med Biol. 2021 Mar;47(3):640-650. doi: 10.1016/j.ultrasmedbio.2020.10.019. Epub 2020 Nov 28.
- Mahapatra S, Francois H, Weber-Levine C, Jiang K, Bhimreddy M, Boateng A, Davidar AD, Routkevitch D, Chhatre A, Manbachi A, Theodore N. Focused ultrasound for the treatment of facet joint pain: a systematic review. Neurosurg Focus. 2024 Sep 1;57(3):E9. doi: 10.3171/2024.6.FOCUS24249.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de julio de 2027
Finalización del estudio (Estimado)
1 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PB002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .