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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Machbarkeit des Geräts
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of scheduled Vysio recording windows containing signal data
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hemorai Inc

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Mai 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

14. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. September 2026

Zuerst gepostet (Tatsächlich)

17. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Vy4-2026-01
  • 20964 (Andere Zuschuss-/Finanzierungsnummer: Center for Advancing Point of Care Technologies (CAPCaT))
  • 1U54HL143541 (US NIH Stipendium/Vertrag)
  • 20263012 (Andere Kennung: Lahey Clinic, Inc. Institutional Review Board)
  • 2414660-1 (Andere Kennung: IRBNet / Lahey Clinic, Inc.)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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