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A study to validate BTL-001-2 ABPM Blood Pressure instrument.

A Clinical Study to Validate BTL-001-2 ABPM (Ambulatory Non-Invasive Blood Pressure Sphygmomanometer) according to the British Hypertension Society Protocol. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/076934
Enrollment
114
Registered
2024-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Intervention1: BTL-001-2 ABPM: Ambulatory Non-Invasive Blood Pressure Sphygmomanometer Control Intervention1: BPMR-111 Regular Blood Pressure monitor manufactured by Diamond®: BPMR-111 Regular Blood

Sponsors

BTL India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects should be at least 15 years of age. 2. Arm circumference between 14 cm - 50 cm. 3. Willing to participate must be able to provide an informed consent or have legally authorized representative consent to participate. 4. Subjects that can tolerate a waiting period for up to 1 hour.

Exclusion criteria

Exclusion criteria: 1.Arm circumference is less than 14 cm or greater than 50 cm. 2. Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB),atrial fibrillation) 3. Korotkoffs sound K1 or K5 not audible. 4. Musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm. 5. Unwilling to volunteer to participate and to sign the study specific informed consent form. 6. Patients suffering with Parkinsonâ??s disease or other diseases with tremors. 7. Patients with coagulation disturbances. 8. Patients with serious mobility or other impairments without supervision. 9. Patients requiring urgency/emergency cardiac care 10. History of bleeding disorder and intake of anticoagulant medication 11. Persistence of Korotkoff sounds until near zero pressure

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to clinically validate non-invasive blood pressure measurement accuracy of the BTL-001-2 ABPM non invasive blood pressure monitoring device to the British Hypertension Society protocol requirements.Timepoint: 1st reading 2nd reading 3rd reading 4th reading 5th reading 6th reading 7th reading—

Secondary

MeasureTime frame
Documenting adverse events (AEs) serious adverse events (SAEs), and device deficienciesTimepoint: 1st reading 2nd reading 3rd reading 4th reading 5th reading 6th reading 7th reading—

Countries

India

Contacts

Public ContactArabinda Patnaik

Syncorp Health Pvt. Ltd.

arvind.p@syncorphealth.com9014308214

Outcome results

None listed

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