| CTRI Number |
CTRI/2024/11/076934 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to validate BTL-001-2 ABPM Blood Pressure instrument.
|
|
Scientific Title of Study
|
A Clinical Study to Validate BTL-001-2 ABPM (Ambulatory Non-Invasive
Blood Pressure Sphygmomanometer) according to the British Hypertension
Society Protocol. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0185-008 |
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 |
8151994080 |
| 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
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 |
Room no-03 Ground Floor Department of general medicine No 67 8 18th Cross 4th main Malleswaram Bengaluru Karnataka India 560055
Bangalore
KARNATAKA |
08151994080
meggydoc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Blood Pressure Monitoring |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BPMR-111 Regular Blood Pressure monitor manufactured by Diamond® |
BPMR-111 Regular Blood Pressure monitor manufactured by Diamond® |
| Intervention |
BTL-001-2 ABPM |
Ambulatory Non-Invasive Blood
Pressure Sphygmomanometer |
|
Inclusion Criteria
Modification(s)
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 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 |
|
|
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 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. |
1st reading
2nd reading
3rd reading
4th reading
5th reading
6th reading
7th 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 |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The purpose of the protocol is to offer evidence of accuracy for the BTL-001-2 Ambulatory
blood pressure monitoring device for the intended use in the adult population as per BHS
protocol. The same arm sequential method with dual observer auscultation will be used to
collect data. The procedure, data collection and data analysis methods that are followed in this
protocol are as per The British Hypertension Society protocol for the evaluation of blood
pressure measuring devices.
The aim is to provide accurate data of non-invasive blood pressure (NIBP) to support validation
of the BTL-001-2 ambulatory blood pressure monitoring device. The anticipated benefits of
this study sought to outweigh the possible risk associated with the device. There are no known
contraindications, other than those noted in study’s exclusion criteria, for use in the proposed
clinical study or study population. |