Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management
12 de junio de 2026 actualizado por: Flat Medical Co., Ltd
Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management: A Prospective, Open-Label, Non-Randomized Comparative Study Versus Conventional Loss-of-Resistance Technique
This study evaluates a new medical device called the EpiFaith™ Syringe, which is designed to help clinicians more accurately identify the epidural space during pain management procedures. The epidural space is a narrow area near the spine where medication is delivered to treat chronic pain conditions. Finding this space correctly is a critical step in procedures such as epidural steroid injections, spinal cord stimulator placement, and minimally invasive lumbar decompression (MILD).
Currently, clinicians locate the epidural space using a method called loss-of-resistance (LOR), which relies on the feel of a syringe plunger as a needle is advanced toward the epidural space. This technique depends on the clinician's experience and touch, and can sometimes result in multiple needle attempts or an incorrect signal that the epidural space has been reached when it has not.
The EpiFaith™ Syringe is designed to provide a clear visual signal, called the Faith Signal, at the moment the epidural space is entered, reducing reliance on touch alone. The device is used with standard epidural needles and does not require additional equipment or significant changes to routine procedure workflow.
This study will enroll 100 adults scheduled for a clinically indicated epidural pain procedure at Innovative Pain Treatment Solutions in Temecula or San Diego, California. Participants will be assigned to have their procedure performed using either the EpiFaith™ Syringe or a standard LOR syringe. The study will compare the number of needle attempts needed to access the epidural space and the rate of false signals between the two methods. Safety and patient-reported pain outcomes will also be collected for approximately one week following the procedure.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
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: Maja Green, PhD, MBA
- Número de teléfono: 858-910-1778
- Correo electrónico: mgreen@solarisresearchinstitute.com
Copia de seguridad de contactos de estudio
- Nombre: Michelle Yi, BSC
- Número de teléfono: 760-846-5822
- Correo electrónico: myi@solarisresearchinstitute.com
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92111
- Innovative Pain Treatment Solutions
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Investigador principal:
- Krishnan Chakravarthy, MD, PhD
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Temecula, California, Estados Unidos, 92590
- Innovative Pain Treatment Solutions
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Investigador principal:
- Krishnan Chakravarthy, MD, PhD
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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:
- Age 18 years or older at the time of informed consent.
- Scheduled to undergo a clinically indicated interventional pain management procedure as part of routine clinical care at the study site.
- Planned procedure requires epidural space localization using the loss-of-resistance technique and is compatible with use of either a conventional loss-of-resistance syringe or the EpiFaith™ syringe, in the judgment of the treating clinician.
- Eligible procedure types include cervical, thoracic, lumbar, or caudal epidural procedures; minimally invasive lumbar decompression (MILD) procedures when epidural access or localization is required; and spinal cord stimulation (SCS) trial epidural access procedures.
- Able and willing to provide written informed consent before any study-specific data collection.
- Able and willing to comply with post-procedure follow-up assessments through approximately 1 week after the procedure, including telephone or telehealth follow-up when applicable.
- For participants receiving anticoagulant or antiplatelet therapy, the treating clinician must determine that the participant can safely undergo the planned epidural procedure according to standard institutional practice and applicable neuraxial anticoagulation guidance.
Exclusion Criteria:
- Inability to provide written informed consent independently, including adults who require consent by a legally authorized representative.
- Known contraindication to the planned epidural procedure, including active infection at the puncture site, uncontrolled coagulopathy, or anticoagulant or antiplatelet status that precludes the planned procedure in the judgment of the treating clinician.
- Known hypersensitivity or contraindication to any standard-of-care medication, contrast agent, or procedural material required for the planned epidural procedure, where such contraindication precludes the procedure.
- Participation in another interventional clinical trial that, in the investigator's judgment, would confound interpretation of study endpoints.
- Any medical, anatomic, procedural, or clinical condition that, in the investigator's judgment, would make study participation unsafe or not in the participant's best interest.
- Pregnancy, unless the epidural procedure is clinically indicated and permitted under the enrolling site's standard clinical practice and IRB-approved procedures.
- Unwillingness or inability to complete required study assessments through approximately 1 week after the procedure.
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: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Conventional LOR Syringe
Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures
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Standard saline loss-of-resistance technique using a conventional epidural syringe.
The clinician applies intermittent or continuous pressure to the syringe plunger while advancing the epidural needle, interpreting a sudden reduction in resistance as entry into the epidural space.
No investigational device is used in this arm.
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Experimental: EpiFaith™ Syringe
EpiFaith™ syringe used in place of conventional LOR technique.
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The EpiFaith™ Syringe is a sterile, single-use piston syringe designed to assist clinicians in identifying the epidural space during neuraxial procedures.
Unlike conventional loss-of-resistance syringes that rely solely on tactile feedback, the EpiFaith™ incorporates a spring-loaded piston mechanism that produces an objective visual indicator, the "Faith Signal," at the moment resistance decreases consistent with epidural space entry.
The device is compatible with standard epidural needles and integrates into routine procedural workflow without significant modification.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Measure number of attempts
Periodo de tiempo: Intra-procedure
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Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
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Intra-procedure
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Measure false loss-of-resistance
Periodo de tiempo: Intra-procedure
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Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care
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Intra-procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measure device related and procedure-related adverse events
Periodo de tiempo: Procedure day through approximately 1 week post-procedure
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Measure: Incidence, nature, and severity of device-related and procedure-related adverse events
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Procedure day through approximately 1 week post-procedure
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Change in pain intensity score on the 11-Point Numeric Rating Scale (NRS)
Periodo de tiempo: Baseline before the procedure on Day 0 and approximately 3 hours, 24 hours, 48 hours, 72 hours, and 7 days after the procedure.
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Pain intensity will be assessed using the 11-point Numeric Rating Scale for pain, scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Change from baseline will be calculated at each post-procedure follow-up time point.
Negative change values indicate improvement, reflecting lower pain intensity compared with baseline.
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Baseline before the procedure on Day 0 and approximately 3 hours, 24 hours, 48 hours, 72 hours, and 7 days after the procedure.
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Clinician Usability Score on a 5-Point Likert Agreement Scale
Periodo de tiempo: Immediately after completion of the index epidural procedure on Day 0, before participant discharge.
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Clinician usability and workflow integration will be assessed immediately after the procedure using a structured post-procedure questionnaire.
The questionnaire evaluates ease of setup and preparation, clarity of the visual indicator, support for stable and controlled needle advancement, confidence in identifying the epidural space, integration into standard workflow, reduction in uncertainty compared with conventional loss-of-resistance technique, overall satisfaction, and willingness to use the device again for similar procedures.
Each item is scored on a 5-point Likert agreement scale from 1 to 5, where 1 indicates strongly disagree, 3 indicates neutral, and 5 indicates strongly agree.
Higher scores indicate better clinician-perceived usability, satisfaction, and workflow integration.
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Immediately after completion of the index epidural procedure on Day 0, before participant discharge.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedure Duration From Skin Puncture to Successful Epidural Access
Periodo de tiempo: During the index epidural procedure on Day 0.
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Procedure duration will be measured as the time from initial epidural needle skin puncture to successful epidural space access during the index procedure.
Duration will be recorded in minutes based on the procedure record or other prespecified time documentation.
Lower values indicate shorter time to epidural access.
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During the index epidural procedure on Day 0.
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Procedure success rate
Periodo de tiempo: During the index epidural procedure on Day 0.
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Procedure success rate will be defined as the proportion of participants in whom successful epidural access is achieved and the intended epidural procedure is completed as planned without procedure abortion or conversion to an alternative non-study approach.
Higher percentages indicate greater procedural success.
Unit of measure: Percentage of participants
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During the index epidural procedure on Day 0.
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Contrast-confirmed epidural spread rate
Periodo de tiempo: During the index epidural procedure on Day 0.
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Contrast-confirmed epidural spread rate will be defined as the proportion of participants with documented epidural contrast spread among participants in whom contrast injection is performed as part of routine clinical care.
Participants in whom contrast is not used per routine care will not be included in the denominator for this outcome measure.
Higher percentages indicate a greater rate of imaging-confirmed epidural spread.
Unit of measure: Percentage of participants with contrast use
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During the index epidural procedure on Day 0.
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Total Fluoroscopy time
Periodo de tiempo: During the index epidural procedure on Day 0.
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Total fluoroscopy time will be recorded for participants in whom fluoroscopy is used as part of routine clinical care during the index epidural procedure.
Fluoroscopy time will be measured in seconds based on the procedure record or fluoroscopy system output.
Lower values indicate shorter fluoroscopy exposure time.
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During the index epidural procedure on Day 0.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Maja Green, PhD, MBA, Solaris Research Institute Inc
- Investigador principal: Krishnan Chakravarthy, MD, PhD, Solaris Research Institute Inc
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)
28 de mayo de 2026
Finalización primaria (Estimado)
27 de septiembre de 2026
Finalización del estudio (Estimado)
28 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 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
- FM-EF-REG-001
- 20261196 (Identificador de registro: WCG IRB)
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.
No
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