An interventional study of Wearable optical hemodynamic monitoring device in Blood Loss, Surgical and Postoperative Hemorrhage, sponsored by Hemorai Inc. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Hemorai Inc · Not applicable, Interventional, and Device feasibility
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. The investigators will also explore whether changes recorded by the device occur around signs or treatments related to blood loss.
The main questions are:
Participants undergoing surgery will wear the device on the upper arm or chest. Trained study staff will apply the device before surgery. The device 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. Nurses will not interpret the device measurements or use the measurements to make treatment decisions.
Hemorai Vysio is an investigational device. The device 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.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →This is the only study on the registry with Hemorai Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Surgical participants:
Nursing participants:
Exclusion Criteria:
Surgical participants:
Nursing participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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. The device 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.
Percentage of scheduled Vysio recording windows containing signal data
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.
Time frame: From device placement before surgery through device removal, up to approximately 54 hours
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
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.
Time frame: From device placement before surgery through device removal, up to approximately 54 hours
Descriptive Vysio Hemoglobin-Related Signal Trajectory by Hemorrhage-Protocol Activation Status
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.
Time frame: From device placement before surgery through device removal, up to approximately 54 hours
Descriptive Vysio Perfusion Index (SFI) Trajectory by Hemorrhage-Protocol Activation Status
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.
Time frame: 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
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.
Time frame: From device placement before surgery through device removal, up to approximately 54 hours
Plan to share: No — 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.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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