None listed
Conditions
Interventions
Intervention1: BTL-001-2 ABPM: The blood pressure will be evaluated using the test device, minimum three times and maximum eight times with an interval of 60 seconds
Control Intervention1: BPMR 111 Re
Sponsors
BTL India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants >= 3 years of age (minimum 30% male/female) 2. Arm circumference between 12 cm - 44 cm. 3. Willing to participate must be able to provide an informed consent or have legally authorized representative consent to participate. 4.Participants who can tolerate sitting for up to 1 hour.
Exclusion criteria
Exclusion criteria: 1. Arm circumference less than 10 cm. or greater than 44 cm. 2. Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) 3. Korotkoff sound K5 not audible. 4. Musculoskeletal disorder that prevents a non-invasive device from being 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. Subjects not ready to stay in hospital for up to 1 hour.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify the accuracy of measure of Systolic and Diastolic functions of BTL-001-2 ABPM device in comparison with reference device.Timepoint: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of any AE a. Due to the cuff (sweat, itching, soreness,) b. device issues Timepoint: Day 1 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed