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Data Collection Study Using CS (CardiacSense) BP (Blood Pressure) Watch and Pillow Systems

2026年8月9日 更新者:CardiacSense Ltd.

A Data Collection Study to Collect Blood Pressure (BP) Data Using the CardiacSense BP Watch and CardiacSense Pillow Systems for Algorithm Development

Collect raw data from CS Watch System, CS BP Pillow System, Arterial line (A-line) and auscultatory cuff measurements in volunteers. The data collected in the study will be used for development of the CS BP algorithms.

研究概览

详细说明

This is a prospective single-site data collection study designed to collect blood pressure (BP) waveforms and estimate BP via the CardiacSense (CS) BP Watch and CS BP Pillow Systems, in parallel with arterial line (A-line data), auscultatory BP cuff measurements and SpO2 measurements. The data collected will be used for algorithms development of the CS BP Systems.

The study includes a screening phase followed by BP data collection session. Participants will be recruited by the Investigator according to the study eligibility criteria. Each enrolled participant will be fitted with 2 CS BP Watches (one on each hand), a CS BP Pillow, A-line and a cuff for auscultatory BP measurement.

A minimum of 100 participants who meet eligibility criteria will be enrolled in the study. After informed consent is obtained, demographic information, medical history, current medication use, Monk Skin Tone Scale, wrist and bicep circumference measurements and baseline vital signs measurements will be recorded. A modified Allen's test, a lateral difference test using non-invasive cuff auscultatory readings and additional assessments will be performed to confirm eligibility criteria.

In participants who meet the eligibility criteria, study devices (CS BP Watch and CS BP Pillow systems) will be fitted, and an A-line will be inserted into the radial artery. A dynamic response calculation will be performed to confirm the integrity of the inserted line.

After the participant has rested for at least 5 minutes, simultaneous BP recordings using both Watches, the Pillow and the A-line will begin and continue for 1 hour. During the 1-hour recording, a few dual-observer auscultatory BP cuff measurements will be performed on the arm contralateral to the A-line arm by two trained observers.

Upon completion of data collection, all devices will be removed, and adverse events will be assessed and documented.

The end of study for each participant is defined as the completion of device removal and after AE follow up by the study team. The end of the trial is defined as the completion of at least 100 valid participant datasets.

研究类型

介入性

注册 (估计的)

100

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。

学习联系方式

学习地点

    • Colorado
      • Louisville、Colorado、美国、80027
        • 招聘中
        • Element Boulder Avista Adventist Hospital Plaza
        • 接触:
        • 接触:
        • 首席研究员:
          • Monica Rabanal, FNP

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Main Inclusion Criteria:

  1. 50-80 years old.
  2. Ability and willingness to sign and understand an informed consent form.
  3. The participant has a palpable radial pulse in both wrists.
  4. The participant is willing and able to be fitted with the investigational devices, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational devices and A-line.
  5. Participant has good signal quality with the CS Pillow at both wrists.
  6. Participant has good PPG signals in both thumbs.
  7. Participant has good ECG signals using the Watch.

Main Exclusion Criteria:

  1. Participant who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the participant or interfere with the data collected.
  2. Participant who has previously participated in a BP study conducted by CardiacSense.
  3. Participant whose body habitus precludes them from wearing the investigational devices.
  4. Female participants who self-reported as pregnant based on a urine pregnancy test, or who are self-reported as trying to get pregnant or who are breastfeeding.
  5. Participant whose BMI is greater than 35.
  6. Participant with a documented medical history of cardiac arrhythmia or if arrhythmia was detected during the screening.
  7. Participant with diagnosed diabetes mellitus.
  8. Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
  9. Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
  10. Participant with pheochromocytoma or primary hyperaldosteronism.
  11. Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
  12. Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
  13. Participant with an infection requiring antibiotics.
  14. Participant with autonomic dysfunction (such as orthostatic hypotension or neuropathy).
  15. Participant with peripheral artery disease
  16. Participants with compromised circulation, including Raynaud's syndrome.
  17. Participant has a fracture, severe trauma, or anatomical deformity involving the wrist or fingers intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
  18. Participant with moderate to severe valvulopathies.
  19. Participant with primary vasculitis.
  20. Participant with tremors or otherwise unable to remain still for 1 hour.
  21. Participants with changes to their antihypertensive medication regimen, including initiation, discontinuation, or dose modification, within 30 days prior to enrollment.
  22. The left to right arm lateral difference of the average systolic blood pressure values is more than 15 mmHg or the lateral difference of the average diastolic blood pressure values is more than 10 mmHg.
  23. Participant belongs to a recruitment category that has already been filled, including BMI category, height category, age group, sex, skin tone category, or blood pressure classification group.
  24. Participant with contact allergy to ultrasound gel.
  25. Participant with prior or known allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine).
  26. Participant with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
  27. Participant with other known health conditions, that might put the participant at risk or might jeopardize the quality of the data collected.
  28. Participant that fails the modified Allen's test (Perfusion Index Ulnar/Ulnar+Radial Ratio test) (Ratio < 0.4).

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:其他
  • 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:CS BP Watch System and CS BP Pillow System
Data collected from the CS BP Watch and Pillow Systems will be compared to data collected from Arterial Line and auscultatory BP cuff measurements

The CS BP Watch System is a wrist-worn data acquisition system designed to estimate BP from time-synchronized ECG and PPG signals.

The CS Pillow System estimates BP using a combination of ECG and tonometry signals. The system is comprised of a tonometry-based sensor which is embedded in a biocompatible "pillow" for improved sensitivity and comfort. The Pillow is placed over the pulsatile area of the radial artery using a wristband. Data collected using the CS Watch and CS Pillow Systems will be compared to data collected using Arterial Line and auscultatory BP cuff measurements

其他名称:
  • Arterial Line

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
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
大体时间:day 1, 1 hour
The primary outcome measure is the number of subjects with complete protocol-defined multi-modal physiological signal acquisition. Multi-modal physiological signal acquisition includes simultaneous recording of: (i) photoplethysmography (PPG); ii) single lead electrocardiography (ECG); iii) tonometry signals from the investigational BP Pillow System ; (iv) continuous invasive arterial blood pressure signals.
day 1, 1 hour

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。

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 (实际的)

2026年7月21日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2026年8月30日

研究注册日期

首次提交

2026年8月2日

首先提交符合 QC 标准的

2026年8月2日

首次发布 (实际的)

2026年8月6日

研究记录更新

最后更新发布 (实际的)

2026年8月11日

上次提交的符合 QC 标准的更新

2026年8月9日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 028_BP_DC_US

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

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