Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery. (VYSIO-FEASIBIL)
2026년 9월 14일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Massachusetts
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Burlington, Massachusetts, 미국, 01805
- Lahey Clinic
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연락하다:
- Shamsher Ali, MS, PhD
- 전화번호: 781-744-2629
- 이메일: Shamsher.Ali@lahey.org
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연락하다:
- Deborah J Gannon, PhD
- 전화번호: 781-744-2734
- 이메일: Deborah.J.Gannon@lahey.org
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수석 연구원:
- Elliot Servais, MD, FACS
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of scheduled Vysio recording windows containing signal data
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
기간: 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.
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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
기간: From device placement before surgery through device removal, up to approximately 54 hours
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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
|
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Descriptive Vysio Perfusion Index (SFI) Trajectory by Hemorrhage-Protocol Activation Status
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Elliot Servais, MD, FACS, Lahey Clinic, Inc.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 15일
기본 완료 (추정된)
2027년 5월 1일
연구 완료 (추정된)
2027년 9월 30일
연구 등록 날짜
최초 제출
2026년 9월 14일
QC 기준을 충족하는 최초 제출
2026년 9월 14일
처음 게시됨 (실제)
2026년 9월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Vy4-2026-01
- 20964 (기타 보조금/기금 번호: Center for Advancing Point of Care Technologies (CAPCaT))
- 1U54HL143541 (미국 NIH 보조금/계약)
- 20263012 (기타 식별자: Lahey Clinic, Inc. Institutional Review Board)
- 2414660-1 (기타 식별자: IRBNet / Lahey Clinic, Inc.)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
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