| CTRI Number |
CTRI/2024/11/076935 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Validation of BTL-001-2 ABPM Blood Pressure Instrument.
|
|
Scientific Title of Study
|
A Clinical Study to Validate the Accuracy of BTL-001-2
ABPM (Ambulatory Non-Invasive Blood Pressure
Sphygmomanometer) in Conformance with ISO 81060 – 2:
2018 + A1:2020 and A2:2024
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0173-008 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghana Murthy |
| Designation |
Consultant Physician |
| Affiliation |
Vagus Super Specialty Hospital |
| Address |
Vagus Super Specialty Hospital Pvt Ltd No 67 8 18th Cross 4th main Malleswaram Bengaluru
Bangalore
KARNATAKA
560055
India |
| Phone |
08151994080 |
| Fax |
|
| Email |
meggydoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arabinda Patnaik |
| Designation |
Associate Director, Project Operations |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No 6 3rd Floor second Main Road sarvobhaogam Nagar Arekere
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Arabinda Patnaik |
| Designation |
Associate Director, Project Operations |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No 6 3rd Floor second Main Road sarvobhaogam Nagar Arekere
Bangalore
KARNATAKA
560076
India |
| Phone |
9014308214 |
| Fax |
|
| Email |
arvind.p@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Vagus Super Specialty Hospital Pvt Ltd No 67 8 18th Cross 4th main Malleswaram Bengaluru Karnataka India 560055 |
|
|
Primary Sponsor
|
| Name |
BTL India Pvt Ltd |
| Address |
7th Floor, Tower 1, Umiya Business Bay, Embassy Tech
Square Main Rd, Kaverappa Layout, Kadubeesanahalli,
Kadubeesanahalli, Bengaluru, Karnataka 560103
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meghana Murthy |
Vagus Super Specialty Hospital |
Department of General Medicine, Room-3, Ground Floor, No 67 8 18th Cross 4th main Malleswaram Bengaluru
Bangalore
KARNATAKA |
08151994080
meggydoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sri Durgamba Independent Ethics Committee |
Approved |
| Sri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Blood Pressure Measurements |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BTL-001-2 ABPM |
ABPM (Ambulatory Non-Invasive Blood Pressure
Sphygmomanometer) |
| Comparator Agent |
Diamond® |
BPMR-111 Regular Blood Pressure monitor manufactured by
Diamond® |
|
Inclusion Criteria
Modification(s)
|
| Age From |
3.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 women |
1st reading
2nd reading
3rd reading
4th reading
5th reading
6th reading
7th reading
8th Reading |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Documenting adverse events (AEs), serious adverse events
(SAEs), and device deficiencies |
1st reading
2nd reading
3rd reading
4th reading
5th reading
6th reading
7th reading
8th Reading |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2024 |
| Date of Study Completion (India) |
18/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The BTL-001-2 ABPM blood pressure monitoring device is planned to be evaluated in a minimum of 200 subjects throughout all study phases that will approximate the distribution of blood pressures as outlined in ISO 81060-2:2018 + A1: 2020 and A2:2024. 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 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 (Ambulatory Non-Invasive Blood Pressure Sphygmomanometer) passes the clinical investigation as per the requirements ISO 81060 – 2: 2018 + A1:2020 and A2:2024 given in sections 5.1 and 5.2 (Phase 1) then it shall undergo investigation in at least 35 adult subjects according to 5.2.6 (Phase 2, ambulatory monitoring) and 5.2 in at least an additional 45 adult pregnant women (Phase 3) and 35 children of age 3-12 years (Phase 4). The prerequisite to initiate Phases 2-4 is a successful result of the Phase 1. 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 (Phase 1). Further no fewer than 35 subjects with a minimum of 11 subjects with a BP >140 mmHg will be analyzed with a minimum of 3 valid pairs in Phase 2. Also, no fewer than 45 pregnant subjects who are normotensive, hypertensive and pre-eclampsia with a minimum of 3 valid pairs will be analyzed in Phase 3. Lastly, no fewer than 35 children of age 3-12 years minimum of 3 valid pairs will be analyzed in Phase 4. At least 90% of the subjects will contribute 3 valid paired observations. |