Blood Loss, SurgicalVYSIO-FEASIBILNCT07826637
Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery.
A study testing Wearable optical hemodynamic monitoring device in people with Blood Loss, Surgical and Postoperative Hemorrhage, run by Hemorai Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical, Postoperative Hemorrhage
- What is being tested?
- Wearable optical hemodynamic monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lahey Clinic
Burlington, Massachusetts, 01805
Shamsher Ali, MS, PhD, 781-744-2629, Shamsher.Ali@lahey.org
Deborah J Gannon, PhD, 781-744-2734, Deborah.J.Gannon@lahey.org
About this study
Official title: 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. The investigators will also explore whether changes recorded by the device occur around signs or treatments related to blood loss.
The main questions are:
Read more
- 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 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.
- Conditions
- Blood Loss, Surgical, Postoperative Hemorrhage
- Being tested
- Wearable optical hemodynamic monitoring device
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable optical hemodynamic monitoring deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemorai Vysio Monitoring | Experimental | 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. Receives: Device: Wearable optical hemodynamic monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From device placement before surgery through device removal, up to approximately 54 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm feasibility study with two consented participant populations. Approximately 60 adult surgical patients will wear the investigational Hemorai Vysio device during surgery and for up to 48 hours postoperatively. Enrollment exceeds 20 surgical participants because hemorrhage-protocol activation is expected in only a subset; approximately 60 surgical patients are planned to obtain about 20 with a qualifying activation during device wear. Approximately 20 bedside nurses will participate in workflow and usability surveys; nurses are not assigned the device. Total anticipated enrollment is 80. There is no comparator, crossover, randomization, blinding, or control arm. Vysio data are analyzed offline and do not guide clinical care.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemorai Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Elliot Servais, MD, FACS, Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826637
- Sponsor's protocol ID
- Vy4-2026-01
- Other IDs
- 1U54HL143541, 20964, 20263012, 2414660-1
- Acronym
- VYSIO-FEASIBIL
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.