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Clinical validation study to assess the performance of the BP Band device to measure blood pressure in people with both normal and high blood pressure compared to the standard mercury BP apparatus.

Clinical Validation Study of BP BAND: A continuous, cuffless blood pressure monitoring device - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/077729
Enrollment
360
Registered
2024-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

None listed

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Imedrix Systems Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants with normal BP, prehypertension, stage 1 hypertension, and stage 2 hypertension. Participants who provide voluntary informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Pregnant women, paediatric, or elderly individuals above the age of 65. Participants with present arrhythmias.

Design outcomes

Primary

MeasureTime frame
Bland-Altman plot analysis will determine the Limits of Agreement (LoA) and their confidence intervals (CI). Agreement is concluded if the confidence intervals lie within the predefined boundary of ?7 mmHg.Timepoint: Measured at baseline and again within 4 weeks

Secondary

MeasureTime frame
Mean differences in systolic & diastolic BP over repeated measurements using Bland-Altman analysis.Timepoint: Measured at baseline & again within 4 weeks;Accuracy of BP Band in distinguishing BP ranges (normal, prehypertension, stage 1 & 2 hypertension).Timepoint: Measured at baseline & again within 4 weeks;Participant adherence rates & feedback on usability through structured surveys.Timepoint: Measured at baseline & again within 4 weeks

Countries

India

Contacts

Public ContactDr Akansha Kumari

Centre for Chronic Disease Control (CCDC)

akansha@ccdcindia.org8766280298

Outcome results

None listed

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