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Data Collection Study Using CS BP Pillow System

2 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Colorado
      • Louisville, Colorado, Verenigde Staten, 80027
        • Element Boulder Avista Adventist Hospital Plaza

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Apparaat: CS BP Pillow System, CS BP Plate System and IR Pillows

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.

Andere namen:
  • Arterial Line

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

CardiacSense Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 februari 2026

Primaire voltooiing (Werkelijk)

30 april 2026

Studie voltooiing (Werkelijk)

30 april 2026

Studieregistratiedata

Eerst ingediend

8 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 027_BP_DC_US

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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