None listed
Conditions
Interventions
Intervention1: BTL-001-2 ABPM: ABPM (Ambulatory Non-Invasive Blood Pressure
Sphygmomanometer)
Control Intervention1: Diamond®: BPMR-111 Regular Blood Pressure monitor manufactured by
Diamond®
Sponsors
BTL India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants grater than or equal 3 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 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 Parkinson’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 For the Phase 2 (ambulatory monitoring) the following exclusion criteria shall apply: 12. History of coronary artery disease with angina on exertion 13. History of allergic airway disease, bronchial asthma or chronic bronchitis 14. Poor exercise tolerance 15. Subjects who are breathless on exertion or at rest 16. Subjects experiencing painful arthritic symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to provide clinical validation to ISO 81060-2:2018 + A1:2020 and A2:2024 for non-invasive blood pressure measurement accuracy for the BTL-001-2 ABPM non-invasive blood pressure monitoring device on the intended population including Ambulatory BP monitoring and pregnant womenTimepoint: 1st reading 2nd reading 3rd reading 4th reading 5th reading 6th reading 7th reading 8th Reading | — |
Secondary
| Measure | Time 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 8th Reading | — |
Countries
India
Contacts
Public ContactArabinda Patnaik
Syncorp Health Pvt. Ltd.
Outcome results
None listed