Strap-On sensor aims to catch hidden blood loss in surgery
NCT ID NCT07826637
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether a strap-based wearable optical device can safely and feasibly track relative changes in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use during and after inpatient surgery. Participants wear the device on the upper arm or chest for up to 48 hours after surgery while receiving standard care. The trial also explores whether device measurements change around signs or treatments related to blood loss, and how comfortable and practical the device is for patients and bedside nurses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a strap-based wearable optical monitoring device (Hemorai Vysio)
- What this could lead to
- If it works, this could give surgical teams a noninvasive way to spot early signs of blood loss and guide timely treatment.
- What could go wrong
- The device is investigational and not approved for clinical use. It may fail to collect usable data, cause skin irritation, or its measurements may not reliably track real changes in blood loss.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lahey Clinic
Burlington, Massachusetts, 01805, United States
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