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A study to improve the accuracy of Blood Pressure data of Valencell Finger clip and watch using standard method.

A prospective observational study for the development of accuracy data to support the development of Valencell finger clip and watch blood pressure systems using same arm sequential method.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/01/062053
Enrollment
1000
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R688- Other general symptoms and signs

Interventions

Intervention1: Nil: Nil Intervention2: Valencell finger clip and watch blood pressure systems: Photoplethysmography (PPG) developmental data for the Valencell prototype finger clip and watch blood pre

Sponsors

Valencell, Inc.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants must be able to provide an informed consent or have legally authorized representative consent to participate. 2.Participant must be willing and able to comply with the study procedures. 3.Participant must be = 18 years of age. 4.Participants with a upper arm circumference in the range of the reference cuff 5.Participants who fit in one of the following categories with a goal of 15% minimum in each and up to 15% can fall outside of these categories: a.Age Group 18-30: Any BP systolic over 140 mmHg. b.Age Group 18-30: Overweight(BMI >25) with BP systolic under 100 mmHg. c.Age Group 30+: Any with BP systolic over 160 mmHg. d.Age Group 30+: Any with BP systolic under 100 mmHg. e.Age Group 18+: With any BP.

Exclusion criteria

Exclusion criteria: • Lack of Informed consent. • Participants with deformities or abnormalities that may prevent proper application of the device under test. • Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study. • Participants with known heart dysrhythmias. • Participants with compromised circulation or peripheral vascular disease. • Participants who are pregnant and/or lactating. • Participants who cannot tolerate sitting for up to 30 minutes. • Participant falls into a category that has already been filled

Design outcomes

Primary

MeasureTime frame
1.Photoplethysmography (PPG) developmental data for the Valencell prototype finger clip and watch blood pressure systems on the intended population. 2.Systolic and diastolic blood pressure as measured by Reference sphygmomanometer. Timepoint: Day 1 (Single visit study- 03 reading within 30 mins)—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactKaarkki Kailasam

Techobserver India Pvt Ltd

amit.bobde@tech-observer.com8007705007

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026