- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04685330
Portable Ultrasound for Interventional Procedures
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Portable ultrasound-guided procedures, including paracentesis, thoracentesis, drain placement, or simple biopsies can be required for patients who are difficult to move, in particular COVID-19 patients, patients in the ICU, or on the floor. Portable ultrasounds have demonstrated a convenient ability to provide a point of care ultrasound diagnostic testing with expanding use in standard clinical care. A number of portable ultrasound systems are in routine clinical use at MGH and have been used for diagnostic procedures (e.g. Butterfly, Hologic, others). Most of the systems are still tethered (transducer is connected via cables to a computer or power) which may represent challenges for contamination, especially in interventional procedures. The Healcerion system is the first FDA approved wireless and battery-operated portable ultrasound system of its kind and is in routine use for diagnostic ultrasounds throughout the world.
The goal of the current study is to compare the utility and practical operations of the advanced Healcerion SONON ultrasound system to a standard wheeled and bulky ultrasound systems in current use (Hitachi, GE). While the Healcerion device has been used at other institutions, it has not been used for interventional procedures at MGH. A comparative efficacy study will allow the investigators to examine the safety and efficacy of the device to complete procedures in a portable setting as well as explore whether images can be improved to reach the more robust imaging capability of wired devices.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Avik Som, MD
- Número de teléfono: +1-832-330-7557
- Correo electrónico: Avik.Som@MGH.HARVARD.EDU
Copia de seguridad de contactos de estudio
- Nombre: Hyungsoon Im, PhD
- Número de teléfono: +1-617-643-5679
- Correo electrónico: im.hyungsoon@mgh.harvard.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- The subject has read, signed, and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
- Age ≥ 18 years at the date of informed consent form signature and having the ability to comply with the protocol.
- Undergoing a clinically indicated ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy.
Exclusion Criteria:
- Patient or health care proxy does not consent
- Patient not undergoing an ultrasound-guided procedure.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Adult patients undergoing an ultrasound-guided procedure
Adult patients undergoing an ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy
|
Single-arm, open-label device efficacy study to enroll 200 patients who have been ordered to have an ultrasound-guided procedure by the MGH Interventional Radiology department, including paracentesis, thoracentesis, biopsy, or ultrasound-guided drain placement.
Patients will be restricted to adults who can consent.
The FDA approved Healcerion SONON portable ultrasound (linear and curved) will be used during clinically indicated standard ultrasound-guided procedures following clinical standard of care.
A standard clinical ultrasound will subsequently be used for image guidance as the gold standard.
Images will be compared and improved.
The efficacy of the portable ultrasound will be monitored by the clinical user and any complications within 30 days will be determined by chart review.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Efficacy > 80%
Periodo de tiempo: Approximately 3 years
|
Efficacy as defined by the operator in successfully completing the procedure using the portable ultrasound.
Reported % of cases the portable ultrasound successfully completed the procedure, stratified by procedure type.
|
Approximately 3 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- 2020P003984
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.
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