Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
NCT ID: NCT06368206
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
85 participants
INTERVENTIONAL
2024-06-25
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring
All study participants will test the investigational device (Aktiia G2C) and other marketed devices for blood pressure and pulse rate measurements (Aktiia Bracelet G2, Double auscultation, oscillometric monitors, finger pulse oximeter).
Investigational device Aktiia G2C
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
Marketed device used as reference for blood pressure monitoring: double auscultation cuff
Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
Marketed device used as reference for pulse rate monitoring: pulse finger oximeter
Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.
Interventions
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Investigational device Aktiia G2C
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
Marketed device used as reference for blood pressure monitoring: double auscultation cuff
Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
Marketed device used as reference for pulse rate monitoring: pulse finger oximeter
Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.
Eligibility Criteria
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Inclusion Criteria
* Subjects fluent in written and spoken French
* Subjects agreeing to attend the study visit and follow study procedures
* Subjects that have signed the informed consent form.
Exclusion Criteria
* Damaged/injured skin at index fingers
* Damaged/injured skin at wrists
* Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation
* Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
* Pregnant women
* Polyneuropathy
21 Years
85 Years
ALL
Yes
Sponsors
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Aktiia SA
INDUSTRY
Responsible Party
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Locations
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CHUV
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Grégoire Wuerzner, MD Prof
Role: primary
Other Identifiers
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OBPM_Calfree2024
Identifier Type: -
Identifier Source: org_study_id