| CTRI Number |
CTRI/2024/01/062053 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Blood pressure data collection |
| Study Design |
Other |
|
Public Title of Study
|
A study to improve the accuracy of Blood Pressure data of Valencell Finger clip and watch using standard method. |
|
Scientific Title of Study
|
A prospective observational study for the development of accuracy data to support the development of Valencell finger clip and watch blood pressure systems using same arm sequential method. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PR2022-476 Version 1.0 dated 21-Apr-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajneesh kapoor |
| Designation |
Chairman-Interventional Cardiology |
| Affiliation |
Medanta The Medicity |
| Address |
Room Number 27, 3rd floor, Medanta The Medicity
Sector 38
Gurgaon
HARYANA
122001
India |
| Phone |
9971991740 |
| Fax |
|
| Email |
rajneesh.Kapoor@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Arvind Bobde |
| Designation |
Sr. Manager Medical Monitoring |
| Affiliation |
Techobserver India Pvt Ltd |
| Address |
No 219, Second floor, Lodha Supremus 2, Road no 22, Wagle Industrial Estate, Thane West
Thane
MAHARASHTRA
400604
India |
| Phone |
8007705007 |
| Fax |
|
| Email |
amit.bobde@tech-observer.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaarkki Kailasam |
| Designation |
Project Manager |
| Affiliation |
Techobserver India Pvt Ltd |
| Address |
No 219, Second floor, Lodha Supremus 2, Road no 22, Wagle Industrial Estate, Thane West
Thane
MAHARASHTRA
400604
India |
| Phone |
8971730898 |
| Fax |
|
| Email |
kaarkki.kailasam@tech-observer.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Valencell, Inc. |
| Address |
4601 Six Forks Road, Suite 103, Raleigh, NC 27609 |
| Type of Sponsor |
Other [Medical Device Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dilip Shah |
Kasturi Medicare Pvt. Ltd. |
OPD no 4, OPD block, ground floor, Harsh nikeetan, behind Navrang Hotel, Bhyandar(W), Maharashtra-401101
Mumbai
MAHARASHTRA |
9820324286
drdilipshah04@gmail.com |
| Dr Rajneesh Kapoor |
Medanta - The Medicity |
Room Number 27, 3rd floor, Sector 38, Gurugram, Haryana 122001
Gurgaon
HARYANA |
9971991740
rajneesh.Kapoor@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee Vijay Vallabh Hospital |
Approved |
| Medanta Institutional Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants must be able to provide an informed consent or have legally authorized representative consent to participate.
2.Participant must be willing and able to comply with the study procedures.
3.Participant must be ≥ 18 years of age.
4.Participants with a upper arm circumference in the range of the reference cuff
5.Participants who fit in one of the following categories with a goal of 15% minimum in each and up to 15% can fall outside of these categories:
a.Age Group 18-30: Any BP systolic over 140 mmHg.
b.Age Group 18-30: Overweight(BMI>25) with BP systolic under 100 mmHg.
c.Age Group 30+: Any with BP systolic over 160 mmHg.
d.Age Group 30+: Any with BP systolic under 100 mmHg.
e.Age Group 18+: With any BP.
|
|
| ExclusionCriteria |
| Details |
• Lack of Informed consent.
• Participants with deformities or abnormalities that may prevent proper application of the device under test.
• Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
• Participants with known heart dysrhythmias.
• Participants with compromised circulation or peripheral vascular disease.
• Participants who are pregnant and/or lactating.
• Participants who cannot tolerate sitting for up to 30 minutes.
• Participant falls into a category that has already been filled
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Photoplethysmography (PPG) developmental data for the Valencell prototype finger clip and watch blood pressure systems on the intended population.
2.Systolic and diastolic blood pressure as measured by Reference sphygmomanometer.
|
Day 1 (Single visit study- 03 reading within 30 mins)
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
15/02/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 PPG technology enables continuous and non-invasive blood
pressure measurement using wearable devices. The PPG signals are easily
acquired from an optical sensor of a wearable device applied to the epidermis
and used to estimate blood pressure. This principle is used for the development
of various new instruments and sensor-based systems which are integrated with
computer-based healthcare systems to support continuous and remote monitoring
of assisted living The study is being done for the development of non-invasive
accuracy data of systolic and diastolic blood pressure measurements to support
the development of wearable finger clips and watch blood pressure systems in
adults. The device under test will be built according to the Valencell design
control processes. The device will include the Valencell prototype finger clip
and watch connected to a laptop via USB through a Valencell USB development
platform. Device model numbers, serial numbers, date(s) of use, participant ID
number(s) will be recorded on the Case Report Forms.
The sensor clip will be applied to the finger and the watch
is applied to the wrist. Once the data collection is done, they will remove.
The maximum duration it will take is of 30 minutes. |