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Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery. (VYSIO-FEASIBIL)

14 de septiembre de 2026 actualizado por: Hemorai Inc

Feasibility Evaluation of a Strap-Based Wearable Optical Device (Hemorai Vysio) for Monitoring Hemodynamic Trends and Early Indicators of Blood Loss in Perioperative and Postoperative Patients

The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use during and after inpatient surgery. The device does not provide absolute clinical measurements. Researchers will also explore whether changes recorded by the device occur around signs or treatments related to blood loss.

The main questions are:

  • Can the device collect usable information during and after surgery without interfering with routine care?
  • What device-related problems, such as skin irritation or discomfort, occur?
  • Do changes in the device measurements occur around changes in blood pressure, laboratory results, fluid administration, or blood transfusion?
  • How comfortable and practical is the device for participants and bedside nurses?

Participants undergoing surgery will wear the device on the upper arm or chest. Trained study staff will apply it before surgery. It will remain in place for up to 48 hours after surgery, or until discharge or earlier removal. Participants will continue to receive usual hospital monitoring and care.

Bedside nurses may also join the study and complete a short voluntary survey. Nurses may check the device position and adjust the strap for comfort. They will not interpret the device measurements or use them to make treatment decisions.

Hemorai Vysio is an investigational device. Its measurements will be analyzed for research and will not be used to guide participants' medical care. Participants are not expected to receive a direct medical benefit from taking part.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

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

  • Estados Unidos
    • Massachusetts
      • Burlington, Massachusetts, Estados Unidos, 01805
        • Lahey Clinic
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Elliot Servais, MD, FACS

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

Surgical participants:

  • 18 to 85 years of age
  • Undergoing inpatient surgery with an expected overnight hospital stay
  • Capable of providing informed consent
  • No anticipated contraindications to skin-worn sensors
  • Hemodynamically stable at enrollment, with no vasopressor requirement

Nursing participants:

  • Bedside nurse caring for an enrolled surgical participant during the Vysio device-wear period
  • Capable of providing informed consent for the study-related usability survey
  • Willing to complete the voluntary usability survey

Exclusion Criteria:

Surgical participants:

  • Pregnancy; participants of childbearing potential with a positive pregnancy test before surgery
  • Prisoner
  • Cognitive impairment or inability to provide informed consent
  • Hemodynamic instability requiring vasopressors at enrollment
  • Severe dermatitis or another skin condition at the planned device application site
  • Known allergy or prior adverse reaction to silicone elastomer, thermoplastic elastomer, or components of the self-adherent elastic wrap (cotton/polyester substrate or synthetic elastic yarn)
  • Active skin breakdown, dermatitis, eczema, burns, or a surgical incision at the planned strap contact site
  • Condition compromising skin integrity such that the site would not qualify as intact skin under ISO 10993-1:2018

Nursing participants:

  • Not caring for an enrolled surgical participant during the Vysio device-wear period
  • Unable or unwilling to provide informed consent

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: Viabilidad del dispositivo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Hemorai Vysio Monitoring
Adult surgical participants will wear the investigational Hemorai Vysio device on the upper arm or chest during surgery and for up to 48 hours after surgery, or until earlier discharge, withdrawal, or clinically indicated removal. The device records research-only optical signals in parallel with standard care. Device data will be analyzed offline and will not be used to guide clinical decisions.
Dispositivo: Wearable optical hemodynamic monitoring device
An investigational, non-FDA-approved strap-based wearable optical device placed on the upper arm or chest by trained study staff. It records intermittent 2-minute optical signal windows every 15 minutes during surgery and for up to 48 hours postoperatively. Research outputs include relative trends in local tissue oxygenation (StO2), hemoglobin-related signals, perfusion index (SFI), and tissue oxygen consumption (tMRO2). The device operates in parallel with standard-of-care monitoring; data are analyzed offline and are not used for clinical decisions.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of scheduled Vysio recording windows containing signal data
Periodo de tiempo: From device placement before surgery through device removal, up to approximately 54 hours
For each patient participant, the number of scheduled 2-minute Vysio recording windows containing recorded signal data will be divided by the number of scheduled windows during device wear and multiplied by 100. The percentage will be summarized descriptively across participants as a measure of device-data completeness.
From device placement before surgery through device removal, up to approximately 54 hours

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
Periodo de tiempo: From device placement before surgery through device removal, up to approximately 54 hours
Relative local tissue oxygenation (StO2) trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group). Values will also be time-aligned with documented hypotension, transfusion, fluid administration, and serial hemoglobin and hematocrit results. Pearson or Spearman correlations may be calculated where appropriate. Analyses are exploratory and will not estimate diagnostic performance.
From device placement before surgery through device removal, up to approximately 54 hours
Descriptive Vysio Hemoglobin-Related Signal Trajectory by Hemorrhage-Protocol Activation Status
Periodo de tiempo: From device placement before surgery through device removal, up to approximately 54 hours
Relative hemoglobin-related signal trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group). These device-derived relative trends are not systemic hemoglobin concentrations. Values will be time-aligned with documented hypotension, transfusion, fluid administration, and serial laboratory hemoglobin and hematocrit results. Pearson or Spearman correlations may be calculated where appropriate. Analyses are exploratory and will not estimate diagnostic performance.
From device placement before surgery through device removal, up to approximately 54 hours
Descriptive Vysio Perfusion Index (SFI) Trajectory by Hemorrhage-Protocol Activation Status
Periodo de tiempo: From device placement before surgery through device removal, up to approximately 54 hours
Relative perfusion index (SFI) trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group). SFI is a relative device-derived perfusion trend and not an absolute tissue perfusion measurement. Values will be time-aligned with documented hypotension, transfusion, fluid administration, and serial hemoglobin and hematocrit results. Pearson or Spearman correlations may be calculated where appropriate. Analyses are exploratory and will not estimate diagnostic performance.
From device placement before surgery through device removal, up to approximately 54 hours
Descriptive Vysio Tissue Oxygen Consumption (tMRO2) Trajectory by Hemorrhage-Protocol Activation Status
Periodo de tiempo: From device placement before surgery through device removal, up to approximately 54 hours
Relative tissue oxygen consumption (tMRO2) trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group). tMRO2 is a relative device-derived trend and not an absolute calibrated metabolic rate. Values will be time-aligned with documented hypotension, transfusion, fluid administration, and serial hemoglobin and hematocrit results. Pearson or Spearman correlations may be calculated where appropriate. Analyses are exploratory and will not estimate diagnostic performance.
From device placement before surgery through device removal, up to approximately 54 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hemorai Inc

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)
University of Massachusetts, Worcester

Investigadores

  • Investigador principal: Elliot Servais, MD, FACS, Lahey Clinic, 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)

15 de octubre de 2026

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

30 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Publicado por primera vez (Actual)

17 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Vy4-2026-01
  • 20964 (Otro número de subvención/financiamiento: Center for Advancing Point of Care Technologies (CAPCaT))
  • 1U54HL143541 (Subvención/contrato del NIH de EE. UU.)
  • 20263012 (Otro identificador: Lahey Clinic, Inc. Institutional Review Board)
  • 2414660-1 (Otro identificador: IRBNet / Lahey Clinic, Inc.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There is no current plan to make individual participant data available to researchers outside the IRB-approved study team. De-identified study data will be stored on a secure Hemorai server, with access limited to trained, IRB-approved study team members.

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

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. .

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