Clinical trials: Wrist Blood Pressure Measurements
Blood Pressure
Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020
The accuracy and safety of the Wrist Ambulatory Blood Pressure Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.
- Trial name
- NCT06573216
- Testing
- Wrist Ambulatory Blood Pressure Monitor
- Where
- China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Huawei Device Co., Ltd
Blood Pressure
Clinical Trial of Wrist Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2019/A1:2020 Standard
The accuracy and safety of wrist blood pressure (model: MLY-B10) is evaluated according to the requirement of EN ISO 81060-2:2019/A1:2020.
- Trial name
- NCT05482035
- Testing
- wrist blood pressure monitor
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Huawei Device Co., Ltd
Hypertension, Blood Pressure
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us…
- Conditions
- Hypertension, Blood Pressure, Heart Rate
- Trial name
- NCT05236348
- Testing
- Aktiia.product-us
- Where
- Switzerland
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Hypertension
Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring Device At Wrist Against Double Auscultation
This study, with N = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23…
- Trial name
- NCT06565780
- Testing
- Device under test evaluation against references
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Blood Pressure
Validation of Wrist Type Oscillometric Blood Pressure Monitorings
Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular.
- Trial name
- NCT04633785
- Testing
- No Intervention
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Blood Pressure
Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)
The purpose of this study is to monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm.
- Trial name
- WBPMCT (NCT00952965)
- Where
- China
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Andon Health Co., Ltd
Hypertension
OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7…
- Trial name
- OBPM_PANDA2026 (NCT07507903)
- Testing
- Device under test evaluation against references
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Hypertension
Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard
The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer measurements via an aneroid sphygmomanometer…
- Trial name
- NCT04869826
- Testing
- Pulsewave Health Monitor (PAD-2A) Device
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Cardiovascular Research New Brunswick
Efficacy of Wrist BPM Measurement, Hypertension
Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard
The clinical protocol of the clinical testing of this device: 1. Objective of the test: To verify the efficiency of device. 2. Test methods and procedures: Clinical test in two positions: Seated and Supine. 3.
- Trial name
- WristBPM01 (NCT01662947)
- Testing
- Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117, Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Leo Wang
Low Blood Pressure, Normal Blood Pressure
Clinical Trial of H2-BP Electronic Sphygmomanometer
The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm.
- Conditions
- Low Blood Pressure, Normal Blood Pressure, Prehypertension, Hypertension
- Trial name
- NCT06491433
- Testing
- H2-BP
- Where
- South Korea
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Gangnam Severance Hospital
Blood Pressure
Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.
The accuracy and safety of the Wrist Ambulatory Blood Pressure Monitor (Model: RIV-B10) were assessed according to the requirements of ISO 81060-2:2018+AMD1:2020+AMD2:2024.
- Trial name
- NCT07713576
- Testing
- Wrist Ambulatory Blood Pressure Monitor/mercury sphygmomanometer
- Where
- China
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Huawei Device Co., Ltd
Blood Pressure Monitoring
Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor
Getting an accurate blood pressure (BP) reading is essential for diagnosing high blood pressure and managing it effectively. High blood pressure is a major health problem, causing about 9.4 million deaths worldwide each year.
- Trial name
- NCT07297277
- Where
- United Kingdom
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Northumbria University
Blood Pressure
Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the…
- Trial name
- NCT04027777
- Testing
- Aktiia.product-P0
- Where
- Switzerland
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Blood Pressure
Comparing Accuracy Between Cuffless Wrist Worn and Cuffed Ambulatory BP Monitoring Devices
Wrist worn devices can help record Blood Pressure (BP) throughout the day. As such devices are becoming increasingly affordable, they could help improve awareness, early diagnosis, and treatment of high and uncontrolled BP.
- Trial name
- Continuum BP (NCT06573801)
- Testing
- Aktiia Bracelet, Healthstats BPro Evo, Spacelabs OnTrak Ambulatory Blood Pressure monitor
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Queen Mary University of London
Blood Pressure
Wrist-based Blood Pressure Monitoring Study
To observe blood pressure variation in various real-world settings
- Trial name
- NCT03661112
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Scripps Translational Science Institute
Blood Pressure
WBPS A Prospective, Method Comparison, Proof of Concept Study
The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to the existing CE-marked WinPack device, compared to two reference devices (one oscillometric and one volume-clamp device), in healthy…
- Trial name
- WBPS (NCT02934386)
- Testing
- WinMedical WinPack device
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Hypertension
OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff
The present study, OBPM_COYOTE2024, with N = 255 participants minimum over 1 visit (lasting ~15min), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational device together with Aktiia G2…
- Trial name
- COYOTE2024 (NCT06698536)
- Testing
- Aktiia G2C
- Where
- Switzerland
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Aktiia SA
Hypertension
Clinical Validation of The Combei BP 880 W
Clinical validation of the wrist blood pressure measuring device Combei BP 880 W for home use according to "the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of…
- Trial name
- NCT05883605
- Testing
- Measuring blood pressure
- Where
- France
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- International Society for Vascular Health