Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery. (VYSIO-FEASIBIL)
2026年9月14日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
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Burlington、Massachusetts、美国、01805
- Lahey Clinic
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接触：
- Shamsher Ali, MS, PhD
- 电话号码：781-744-2629
- 邮箱：Shamsher.Ali@lahey.org
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接触：
- Deborah J Gannon, PhD
- 电话号码：781-744-2734
- 邮箱：Deborah.J.Gannon@lahey.org
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首席研究员：
- Elliot Servais, MD, FACS
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of scheduled Vysio recording windows containing signal data
大体时间：From device placement before surgery through device removal, up to approximately 54 hours
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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.
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From device placement before surgery through device removal, up to approximately 54 hours
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
大体时间：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
|
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Descriptive Vysio Hemoglobin-Related Signal Trajectory by Hemorrhage-Protocol Activation Status
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Elliot Servais, MD, FACS、Lahey Clinic, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月15日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年9月30日
研究注册日期
首次提交
2026年9月14日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- Vy4-2026-01
- 20964 (其他赠款/资助编号：Center for Advancing Point of Care Technologies (CAPCaT))
- 1U54HL143541 (美国 NIH 拨款/合同)
- 20263012 (其他标识符：Lahey Clinic, Inc. Institutional Review Board)
- 2414660-1 (其他标识符：IRBNet / Lahey Clinic, Inc.)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.