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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. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Burlington, Massachusetts, Forente stater, 01805
        • Lahey Clinic
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Elliot Servais, MD, FACS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of scheduled Vysio recording windows containing signal data
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hemorai Inc

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Elliot Servais, MD, FACS, Lahey Clinic, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. oktober 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

30. september 2027

Datoer for studieregistrering

Først innsendt

14. september 2026

Først innsendt som oppfylte QC-kriteriene

14. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Vy4-2026-01
  • 20964 (Annet stipend/finansieringsnummer: Center for Advancing Point of Care Technologies (CAPCaT))
  • 1U54HL143541 (U.S. NIH-stipend/kontrakt)
  • 20263012 (Annen identifikator: Lahey Clinic, Inc. Institutional Review Board)
  • 2414660-1 (Annen identifikator: IRBNet / Lahey Clinic, Inc.)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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