| CTRI Number |
CTRI/2025/06/088554 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Development and testing of a new Blood Pressure monitor Using pulse sounds and Signals |
|
Scientific Title of Study
|
Clinical development and validation of a novel non invasive blood pressure measuring device using Korotkoff sounds and oscillometry waveform |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanu Anand and Dr Jerin Jose Cherian |
| Designation |
Scientist E |
| Affiliation |
Clinical Studies and Trials Unit Division, ICMR |
| Address |
Indian Council of Medical Research (ICMR), V Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India
South
DELHI
110029
India |
| Phone |
9811028964 |
| Fax |
|
| Email |
tanu.anand@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanu Anand and Dr Jerin Jose Cherian |
| Designation |
Scientist E |
| Affiliation |
Clinical Studies and Trials Unit Division, ICMR |
| Address |
Indian Council of Medical Research (ICMR), V Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India
South
DELHI
110029
India |
| Phone |
9811028964 |
| Fax |
|
| Email |
tanu.anand@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Siddharth Dhawan |
| Designation |
Director |
| Affiliation |
Walnut Medical Private Limited |
| Address |
Plot no 132, JLPL Industrial Park, Sector 82, Mohali Punjab 160055
Rupnagar
PUNJAB
160055
India |
| Phone |
9650622772 |
| Fax |
|
| Email |
siddharth@walnutmedical.in |
|
|
Source of Monetary or Material Support
|
| Walnut Medical Private Limited, Plot: 132, JLPL Industrial Park, Sector 82, Mohali Punjab 160055 |
|
|
Primary Sponsor
|
| Name |
Mr Siddharth Dhawan |
| Address |
Walnut Medical Private Limited, Plot: 132, JLPL Industrial Park, Sector 82, Mohali Punjab 160055 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Udit Narang |
All India Institute of Medical Sciences, Nagpur |
Plot No. 2, Sector-20, MIHAN, Nagpur, Maharashtra, Pin Code: 441108.
Nagpur
MAHARASHTRA |
9930805548
uditnarang@aiimsnagpur.edu.in |
| Dr Arunkumar Radhakrishnan |
Chettinad Hospital and Research Institute |
Chettinad Academy of Research and Education, Ragiv Gandhi Salai (OMR), Kelambakkam, Chennai-603103.
Kancheepuram
TAMIL NADU |
9094752000
arunkumarr@care.edu.in |
| Dr Rishi Tuhin Guria |
Rajendra Institute of Medical Sciences |
Rims Cir, Indraprasth Colony, Bariatu, Ranchi, Jharkhand 834009
Ranchi
JHARKHAND |
9431193507
rishi.guria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| CARE-IHEC for Faculty Research |
Approved |
| Institutional Ethics Committee, AIIMS Nagpur |
Submittted/Under Review |
| Institutional Ethics Committee, RIMS, Ranchi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults and children aged 3 years and above visiting the OPD |
| Patients |
(1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care, (2) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, (3) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (4) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (5) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard BP device |
Mercury based sphygmomanometer. In case if the mercury based sphygmomanometer is not available for various reasons, any other standard BP measuring apparatus such as aneroid sphygmomanometer or oscillometry based digital BP apparatus may be used. |
| Intervention |
Walnut Medical Pvt Ltd.s BP device (Korotkoff sounds and oscillatory waveforms based digital BP apparatus) |
An automated digital BP apparatus that integrates Korotkoff sounds and oscillatory waveforms for BP measurement |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Willingness to provide informed consent and voluntary participation in the study
2. Both normotensive or hypertensive Participants either on treatment or not on treatment for hypertension
3. Special population: pregnancy including pre-eclampsia, midarm circumference of greater than 42 cm and atrial fibrillation |
|
| ExclusionCriteria |
| Details |
1.K1 or K5 of Korotkoff sounds is not audible
2. Participants with systolic BP difference more than 12 mmHg and/or diastolic BP difference more than 8 mmHg in any 2 of the 4 reference (average of two observers) BP measurements (R1 to R4)
3. BP measurement beyond the desired target reading of the measuring apparatus
4. Midarm circumference and cuff size beyond the desired target
5. Target population beyond the desired special groups |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Development phase:
1. Display of BP reading by index device through the integration of Korotkoff sounds and oscillatory waveform
Validation phase:
1. Frequency of tolerable error of less than or equal to 5 mmHg
2. Whether estimated tolerable error (less than or equal to 5 mmHg) is found in at least 85% cases
3. Level of accuracy
i. High accuracy: The estimated error (difference between the reference and test device measurement) of less than or equal to 5 mmHg is found in at least 85% cases
ii. Moderate accuracy: The estimated error (difference between the reference and test device measurement)of more than 5 mmHg but less than or equal to 10 mmHg is found in at least 85% cases
iii. Low accuracy: The estimated error (difference between the reference and test device measurement)of more than 10 mmHg is found in at least 85% cases |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Development phase:
1. Any adverse event associated with the use of the device in the participants
Validation phase:
1. Validation of the index device with different cuff size and special population like participants with pregnancy, arm circumference more than 42 cm, and atrial fibrillation.
2. Any adverse event associated with the use of the device in the participants |
one time |
|
|
Target Sample Size
|
Total Sample Size="1620"
Sample Size from India="1620"
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)
|
01/07/2025 |
| 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="1"
Months="0"
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
|
Hypertension is a major
non-communicable disease contributing significantly to global morbidity and
mortality. Accurate blood pressure (BP) measurement is essential for diagnosis,
treatment, and prevention of complications. Traditional mercury sphygmomanometers
using Korotkoff sounds, though considered the gold standard, require trained
personnel, are time-consuming, and pose environmental risks. Automated
oscillometric devices are now widely used due to their ease of operation but
may show significant inaccuracies (up to plus or minus 15 mmHg). Therefore,
there is a need for more accurate devices.
The objective of this
study is to clinically develop and validate a novel BP device (Walnut Pvt Ltd)
integrating both Korotkoff sounds and oscillometric waveforms to enhance
accuracy.
The study will be a
multicenter experimental trial involving 1020 participants in the development
phase and 600 participants in the validation phase, including general and
special populations (pregnant women, atrial fibrillation, mid-arm circumference
more than 42 cm).
Participants will
undergo BP measurement with both the novel device and the standard reference
device as per AAMI/ESH/ISO protocols. Validation will involve sequential BP
measurements, stringent inclusion/exclusion criteria, and supervised
assessments. Acceptable performance will be defined as less than or equal to 5
mmHg mean difference in at least 85% of cases. Data will be analyzed using
SPSS, and results presented via mean differences, standard deviations, and
Bland-Altman plots. Special population data, such as those with pre-eclampsia,
will be separately analyzed.
The study aims to support the development of a user-friendly, accurate,
non-invasive BP measuring device suitable for adults and children across
diverse populations. |