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Clinical trial assessing the accuracy and efficacy of V-Chek ,Cuffless Blood pressure monitoring device compared to Traditional Cuff-Based Methods in Adult Indian Patients with Hypertension

Validation of Cuffless and Finger based Cutting edge technology to measure Blood Pressure (BP) for management of Hypertension - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/12/060564
Enrollment
250
Registered
2023-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: I131- Hypertensive heart and chronic kidney disease without heart failure

Interventions

Intervention1: Cuffless and finger-based blood pressure monitor (New Device): Non-invasive, cuffless blood pressure monitoring device Measures systolic, diastolic, and mean arterial pressure (SBP, DBP

Sponsors

Evercons Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Hypertension, Diabetic and/or other cardiovascular diseases. Additionally healthy employees of the institution with above 25 years

Exclusion criteria

Exclusion criteria: Minors with below 18 years of age and above 85 years

Design outcomes

Primary

MeasureTime frame
Mean difference in systolic blood pressure (SBP) between the new cuffless and finger-based BP monitor device and the mercury-based sphygmomanometer (gold standard)Timepoint: Baseline

Secondary

MeasureTime frame
Intraclass correlation coefficient (ICC): This measure will assess the agreement between VChek and traditional cuff-based methods in terms of individual blood pressure measurements. 2. Bland-Altman limits of agreement (LOA): These limits will provide a visual representation of the variability in blood pressure measurements between V-Chek and traditional methods. This document is an unpublished preview, not for official use 3. Patient adherence to blood pressure monitoring: This measure will assess the frequency and consistency with which participants use their assigned blood pressure monitoring device. 4. Blood pressure control: This measure will assess the proportion of participants who achieve and maintain blood pressure targets throughout the trial.Timepoint: 6 monhts

Countries

India

Contacts

Public ContactDr Rahul Patil

Sri Jayadeva Institute of Cardiovascular Sciences and Research

dr.rahulspatil85@gmail.com8129704541

Outcome results

None listed

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