A Clinical Study to Validate the Accuracy of BTL-001-2 ABPM (Automated Non-Invasive Blood Pressure Sphygmomanometer) in Conformance with AAMI/ANSI/ BHS/ESH-IP/ISO81060-2:2013/ISO81060–2:2018 & A1:2020
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- BTL India Pvt Ltd
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- Verify the accuracy of measure of Systolic and Diastolic functions of BTL-001-2 ABPM device in comparison with reference device.
Overview
Brief Summary
The BTL-001-2 ABPMblood pressure monitoring device will be evaluated in a total of 100 subjects that will approximate the distribution of blood pressures as outlined in ISO 81060-2:2013 / ISO 81060-2:2018 + A1: 2020. The maximum number of subjects enrolled will not exceed 100 subjects. Two trained observers who are medical professionals will observe (listen to) the Korotkoff sounds at the brachial artery of the arm. The reference blood pressure measurements by the medical professionals will be performed sequentially with the device under test. The medical professionals will complete 1 or 2 initial baseline auscultatory reference blood pressure measurements and device under test (BTL-001-2 ABPM) measurements. This is followed by minimum 3 and a maximum of 8 valid paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements.
Once the BTL-001-2 ABPM (Automated Non-Invasive Blood Pressure Sphygmomanometer) passes the clinical investigation as per the requirements ISO81060-2:2013/ISO 81060 – 2: 2018 + A1:2020 (given in sections 5.1 and 5.2), then it shall undergo clinical investigation according to 5.2 in at least an additional 45 pregnant (special) population.
It is expected that the data collection will take up to approximately 1 hour per subject. There is no additional follow-up required for the study.
For accuracy claims, the test device measurements will be compared to those made by the reference device. The data for the final analysis will contain no fewer than 85 subjects with a minimum of 255 valid paired observations. At least 90% of the subjects will contribute 3 valid paired observations. In this case, additional subjects shall be used to complete the minimum number of valid paired observations.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 3.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Participants ≥ 3 years of age (minimum 30% male/female)
- •Arm circumference between 12 cm.
- •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
- •Arm circumference less than 10 cm.
- •or greater than 44 cm.
- •Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation)
- •Korotkoff sound K5 not audible.
- •Musculoskeletal disorder that prevents a non-invasive device from being inflated/deflated on the arm.
- •Unwilling to volunteer to participate and to sign the study specific informed consent form.
- •Patients suffering with Parkinson’s disease or other diseases with tremors.
- •Patients with coagulation disturbances.
- •Patients with serious mobility or other impairments without supervision.
- •Subjects not ready to stay in hospital for up to 1 hour.
Outcomes
Primary Outcomes
Verify the accuracy of measure of Systolic and Diastolic functions of BTL-001-2 ABPM device in comparison with reference device.
Time Frame: Day 1
Secondary Outcomes
- Occurrence of any AE(a. Due to the cuff (sweat, itching, soreness,))