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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Burlington, Massachusetts, Verenigde Staten, 01805
        • Lahey Clinic
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Elliot Servais, MD, FACS

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Toestel Haalbaarheid
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of scheduled Vysio recording windows containing signal data
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hemorai Inc

Medewerkers

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 oktober 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

30 september 2027

Studieregistratiedata

Eerst ingediend

14 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 september 2026

Eerst geplaatst (Werkelijk)

17 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Vy4-2026-01
  • 20964 (Ander subsidie-/financieringsnummer: Center for Advancing Point of Care Technologies (CAPCaT))
  • 1U54HL143541 (Subsidie/contract van de Amerikaanse NIH)
  • 20263012 (Andere identificatie: Lahey Clinic, Inc. Institutional Review Board)
  • 2414660-1 (Andere identificatie: IRBNet / Lahey Clinic, Inc.)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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