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

Conditions

• Blood Loss, Surgical
• Postoperative Hemorrhage

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

Interventions

• Wearable optical hemodynamic monitoring device — 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.

Study Details

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.

Key Dates

First listed

Sep 17, 2026

Start date

Oct 15, 2026

Status verified

Sep 2026

Primary completion

May 1, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• 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.

Primary Outcome Measure

Percentage of scheduled Vysio recording windows containing signal data [ Time Frame: From device placement before surgery through device removal, up to approximately 54 hours ]

Locations (1)

Find similar trials in Burlington, MA

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