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

9 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Colorado
      • Louisville, Colorado, Estados Unidos, 80027
        • Recrutamento
        • Element Boulder Avista Adventist Hospital Plaza
        • Contato:
        • Contato:
        • Investigador principal:
          • Monica Rabanal, FNP

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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

Outros nomes:
  • Arterial Line

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de julho de 2026

Conclusão Primária (Estimado)

30 de agosto de 2026

Conclusão do estudo (Estimado)

30 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

2 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de agosto de 2026

Primeira postagem (Real)

6 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 028_BP_DC_US

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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