Algovita Spinal Cord Stimulation System Hi-Fi Study
9 de marzo de 2021 actualizado por: Nuvectra
Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
20
Fase
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.
Ubicaciones de estudio
-
-
Arizona
-
Tucson, Arizona, Estados Unidos, 85712
- Pain Institute of Southern Arizona
-
-
California
-
Newport Beach, California, Estados Unidos, 92660
- Newport Beach Headache & Pain
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Santa Rosa, California, Estados Unidos, 95401
- Summit Pain Alliance
-
-
Colorado
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Colorado Springs, Colorado, Estados Unidos, 80919
- Spinal Diagnostics & Pain Management
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Kansas
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Overland Park, Kansas, Estados Unidos, 66210
- Mid-America PolyClinic & Interventional Pain Management Specialists
-
-
Louisiana
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Shreveport, Louisiana, Estados Unidos, 71105
- WK River Cities Clinical Research Center
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Massachusetts
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Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Brigham & Women's Hospital
-
-
Ohio
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Chillicothe, Ohio, Estados Unidos, 45601
- Adena Spine Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Comprehensive Spine Center at Rhode Island Hospital
-
-
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
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
- Age 18-75 years old at consent.
- Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
- ODI score of 41-80 out of 100 at the Baseline visit.
- Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
- On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
- Willing and capable of providing informed consent.
- Willing and able of complying with the study-related requirements, procedures, and visits.
- Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
- Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.
Exclusion Criteria:
- Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
- Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
- Has a condition currently requiring or likely to require the use of MRI or diathermy.
- Has an existing drug pump, SCS System, or other active implantable device.
- Has any prior SCS experience.
- Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
- For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
- Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
- Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.
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: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Comparador activo: Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
|
|
Comparador activo: Traditional pulse width
Traditional pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Periodo de tiempo: Week 25
|
The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods. |
Week 25
|
|
Rate of serious study-related adverse events (AEs) in each treatment arm
Periodo de tiempo: From Permanent Implant through Week 25
|
The rate of serious study-related AEs.
Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
|
From Permanent Implant through Week 25
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Periodo de tiempo: Week 12 and Months 12, 18 and 24
|
The percentage of participants who experience at least a 50 percent reduction in targeted pain as assessed by Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
|
Week 12 and Months 12, 18 and 24
|
|
Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain as assessed by Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable).
A higher score indicates a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable).
A higher score indicates a higher level of pain.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Clinician Global Impression of Change score in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in disability compared to baseline in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The change from baseline in disability as measured by the Oswestry Disability Index.
The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in quality of life compared to baseline in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Change in patient activity per the Pain Disability Index score in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The change from baseline in patient activity as measured by the Pain Disability Index score.
The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Patient Global Impression of Change score in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
Periodo de tiempo: Weeks 12 and 25, and Months 12, 18 and 24
|
Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
|
Weeks 12 and 25, and Months 12, 18 and 24
|
|
Evaluation of trial success rates
Periodo de tiempo: From Trial Implant to End of Trail
|
The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
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From Trial Implant to End of Trail
|
|
Rate of surgical re-intervention of the SCS system
Periodo de tiempo: From Permanent Implant through Month 24
|
Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
|
From Permanent Implant through Month 24
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Director de estudio: Ben Tranchina, Nuvectra
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 (Actual)
Inicio del estudio
2 de noviembre de 2018
Finalización primaria (Actual)
Finalización primaria
27 de abril de 2020
Finalización del estudio (Actual)
Finalización del estudio
27 de abril de 2020
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
26 de julio de 2018
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2018
Publicado por primera vez (Actual)
Publicado por primera vez
9 de agosto de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
11 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
9 de marzo de 2021
Última verificación
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- CLRE 1092
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.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
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. .