| CTRI Number |
CTRI/2021/01/030427 [Registered on: 13/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating performance of HealthCubed’s AgeWell device |
|
Scientific Title of Study
|
Clinical validation of HealthCubed’s AgeWell device- a patient monitoring system for measuring vital parameters |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Giriraj KV |
| Designation |
Consultant general physician |
| Affiliation |
Rajalakshmi Hospital |
| Address |
Rajalakshmi hospital
Room no -01
Dept. General Medicine
21/1 lakshmipura main road
Vidyaranyapura post
Bangalore
Bangalore
KARNATAKA
560097
India |
| Phone |
|
| Fax |
|
| Email |
drgirirajkv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Rangarajan |
| Designation |
CSO, HealthCubed Inc |
| Affiliation |
HealthCubed India Private Limited |
| Address |
Obeya Pulse,#7, 1, Ulsoor Rd, Yellappa Chetty Layout, Sivanchetti Gardens, Bengaluru, Karnataka
Bangalore
KARNATAKA
560042
India |
| Phone |
|
| Fax |
|
| Email |
radha@healthcubed.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Rangarajan |
| Designation |
CSO, HealthCubed Inc |
| Affiliation |
HealthCubed India Private Limited |
| Address |
Obeya Pulse,#7, 1, Ulsoor Rd, Yellappa Chetty Layout, Sivanchetti Gardens, Bengaluru, Karnataka
Bangalore
KARNATAKA
560042
India |
| Phone |
|
| Fax |
|
| Email |
radha@healthcubed.com |
|
|
Source of Monetary or Material Support
|
| HealthCubed India Private Limited,
Obeya Pulse,#7, 1, Ulsoor Rd, Yellappa Chetty Layout, Sivanchetti Gardens, Bengaluru, Karnataka |
|
|
Primary Sponsor
|
| Name |
HealthCubed India Private Limited |
| Address |
Obeya Pulse,#7, 1, Ulsoor Rd, Yellappa Chetty Layout, Sivanchetti Gardens, Bengaluru, Karnataka 560042 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
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 Giriraj KV |
Rajalakshmi Hospital |
Rajalakshmi hospital
Room no -01
Dept. General Medicine
21/1 lakshmipura main road
Vidyaranyapura post
Bangalore
Bangalore
KARNATAKA |
9448039952
drgirirajkv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of any sex, 18 years and older, can be enrolled in this study.
2. Subjects must consent to participating in the study. |
|
| ExclusionCriteria |
| Details |
â— Pregnant women
â— Smokers
â— Individuals subject to conditions that result in elevated levels of methaemoglobin
â— Subjects exhibiting injuries, intravenous lines, or other abnormalities that, in the opinion
of the investigator, may prevent proper cuff application or functioning.
â— Subjects with compromised circulation or peripheral vascular disease
â— Subjects with clotting disorders or taking blood thinners |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of performance of AgeWell Device in comparison to Philips SureSigns |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feedback from usability perspective by study performed over 50 subjects |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/01/2021 |
| Date of Study Completion (India) |
29/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
COVID-19 has had a significant impact on the health of people across the world. With restrictions in mobility, people have had to postpone or forego visits to the doctor. For those with chronic conditions, this has meant extended periods of time without vital parameters being tested and tracked. These have long term consequences on morbidity and mortality.
To address these issues, patients and healthcare providers are moving towards home based patient monitoring systems that combine point-of-care testing with digital health services. Patients can use such devices from the comfort of their homes and continue to receive care. HealthCubed India Pvt Ltd has designed a multiparametric point-of-care device for home use called AgeWell that measures blood pressure, oxygen saturation, temperature, respiratory rate, heart rate and performs a single channel ECG. The current study is aimed at evaluating its clinical performance.
This trial will compare the performance of AgeWell with FDA approved Philips SureSign VM8 device for the following vital parameters - Blood Pressure, Oxygen saturation, Pulse rate, Respiratory rate, Heart rate and Temperature. |