Estimulación de la médula espinal en el tratamiento del dolor crónico intratable mediante el sistema de neuroestimulación Nalu™ (nPower™-US)
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety with the Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back. Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation System.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is a prospective, multi-center, open-label, single-arm clinical study.
Subjects who meet the protocol specified eligibility criteria and provide documented informed consent will be considered for study participation. On confirmation of eligibility, subjects will undergo a trial with the Nalu Neurostimulation System. Trials will be done per standard clinical practice and per system IFU. Subjects receiving at least 50% reduction in their back pain will receive a permanent implant.
Eligible subjects will receive the Nalu Neurostimulation System per standard surgical and medical practices and will be programmed for stimulation with one or more therapies to optimize pain reduction. All subjects receiving a permanent implant will be followed for 3-months post device activation. They will visit the clinic at 1 month and 3-months follow-up and programming, as required. Visual Analogue Scale (VAS) will be used to capture outcomes for pain, both leg and back. At study completion, subjects will return to standard clinical practice. Adverse Event data will also be collected to support a safety endpoint.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Larkspur, California, Estados Unidos, 94939
- CA Ortho and Spine
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Walnut Creek, California, Estados Unidos, 94598
- IPM Medical Group, Inc.
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20006
- International Spine, Pain and Performance Center
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Florida
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Gainesville, Florida, Estados Unidos, 32607
- The Orthopaedic Institute
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Port Charlotte, Florida, Estados Unidos, 33948
- Southwest Florida Pain Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30326
- Alliance Spine and Pain
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Kansas
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Overland Park, Kansas, Estados Unidos, 66210
- Neuroscience Research Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73106
- SSM Health
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subject is between 21 and 80 years of age at enrollment.
- Subject has chronic (defined as at least 6 months duration), intractable neuropathic pain of legs and/or back; any nociceptive pain must be less prominent than the neuropathic pain.
- Subject's pain is unresponsive to conservative treatment options.
- Subject has a VAS Score of at least 6 in the back and/or leg at screening.
Exclusion Criteria:
- Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
- Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).
- Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).
- Subject has pain in another anatomic region besides the leg(s) and back that would interfere with their ability to accurately report pain (e.g. hip joint pain).
- Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
Plan de estudios
¿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 |
|---|---|
|
Otro: Nalu SCS System
All eligible subjects will receive the Nalu Neurostimulation System |
The Nalu Neurostimulation System is a Spinal Cord Stimulation system |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Responder Rate
Periodo de tiempo: 3 months post device activation
|
Subjects with 50% or greater pain reduction from baseline on the VAS pain scale for leg and/or back |
3 months post device activation
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Shilpa Kottalgi, Nalu Medical
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NAL-01-2020-US
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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