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Data Collection Study Using CS BP Pillow System

2026年8月2日 更新者:CardiacSense Ltd.

A Data Collection Study to Collect Blood Pressure Data Using the CardiacSense BP Pillow System for Algorithm Development

Collect raw data from CS BP Pillow System ,CS BP Plate System, IR (Infrared) PPG (Photoplethysmography) sensors and Arterial line (A-line) 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 data collection single-site study designed to collect blood pressure (BP) waveforms and estimate BP via the CS BP Pillow System, CS BP Plate System and IR-Pillow in parallel with arterial line (A-line data). 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 using the CS Pillow System, CS BP Plate System, IR-Pillows and an A-line. Participants will be recruited by the Investigator according to the study eligibility criteria.

A total of 50 participants who meet eligibility criteria will be enrolled in the study in 3 cohorts: Cohort I and Cohort II will include 20 participants, and Cohort III will include 10 participants.

After informed consent is obtained, demographic information, medical history, current medications use and wrist circumference measurement will be recorded. A modified Allen's test, a lateral difference test and additional assessments will be performed to confirm eligibility criteria. In participants who meet the eligibility criteria, the CS BP study 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 the CS BP Pillow System, CS BP Plate System, IR Pillows and A-line will begin and continue for about 1 hour.

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 completion of adverse event follow-up. The end of the study is defined as completion of 50 evaluable participant datasets

研究类型

介入性

注册 (实际的)

50

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

    • Colorado
      • Louisville、Colorado、美国、80027
        • Element Boulder Avista Adventist Hospital Plaza

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

Inclusion Criteria:

  • 20-80 years old.
  • Ability and willingness to sign and understand an informed consent form.
  • The participant has a palpable radial pulse in both wrists.
  • The participant is willing and able to be fitted with the investigational device, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational device and A-line.
  • The participant was fitted with both CS BP Plate System devices (one for each hand) and CardiacSense technician has determined the measurement quality to be sufficient.

Exclusion Criteria:

  • 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.
  • Participant whose body habitus precludes them from wearing the investigational device on their wrists.
  • 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.
  • Participant whose BMI is greater than 35.
  • Participant with a documented medical history of cardiac arrhythmia.
  • Participant with diagnosed diabetes mellitus.
  • Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
  • Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
  • Participant with pheochromocytoma or primary hyperaldosteronism.
  • Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
  • Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
  • Participant with an infection requiring antibiotics.
  • Participant with peripheral artery disease
  • Participants with compromised circulation, including Raynaud's syndrome.
  • Participant has a fracture, severe trauma, or anatomical deformity involving the wrist intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
  • Participant with moderate to severe valvulopathies.
  • Participant with primary vasculitis.
  • Participant with tremors or otherwise unable to remain still for 1 hour.
  • 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.

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 Pillow System, CS BP Plate System and IR Pillows
Data collected from the systems will be compared to data collected from Arterial Line

Device: CS Pillow System

CS Pillow System estimates blood pressure using ECG and tonometry signals. It includes a tonometry sensor embedded in a biocompatible pillow, positioned over the radial artery with a wristband for improved sensitivity and comfort and ECG chest wet electrodes fitted on the torso.

CS BP Plate System estimates blood pressure using ECG and PPG. The system consists of a handheld, battery-operated Plate with integrated optical and ECG sensors contacted by the thumb.

Infrared (IR) Pillow contain a PPG sensor (IR LED and photodiode) embedded in a biocompatible "pillow. The IR Pillow is placed over the radial artery. This sensor enables estimation of arterial compliance, an important factor influencing the blood pressure-blood volume relationship.

Data collected using the CS BP Pillow System and the CS Plate System will be compared to data collected using Arterial Line.

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) IR PPG signals (v) 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2月10日

初级完成 (实际的)

2026年4月30日

研究完成 (实际的)

2026年4月30日

研究注册日期

首次提交

2026年4月8日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月2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

  • 027_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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