| CTRI Number |
CTRI/2024/01/061589 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Validation of sensor based portable ECG device |
|
Scientific Title of Study
|
Comparative Validation of SANKETLIFE PROPLUS, touch based portable ECG device with standard
ECG machine to detect cardiovascular diseases in diagnosed and undiagnosed section of society: Post marketing
Surveillance Study |
| 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 Surendra Deora |
| Designation |
Additional Professor & Head Cardiology |
| Affiliation |
AIIMS, JODHPUR |
| Address |
Department of Cardiology, AIIMS JODHPUR, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996715 |
| Fax |
|
| Email |
drsdeora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Itra Singh |
| Designation |
Clinical Research Associate |
| Affiliation |
Agatsa Software Pvt. Ltd |
| Address |
B-01, sector 59, Agatsa Software Pvt. ltd., Noida, India, 201301
1102, Pacific, xavier urbtech
sector 168
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
07417455107 |
| Fax |
|
| Email |
itra.singh@agatsa.com |
|
Details of Contact Person
Public Query
|
| Name |
Itra Singh |
| Designation |
Clinical Research Associate |
| Affiliation |
Agatsa Software Pvt. Ltd |
| Address |
B-01, sector 59, Agatsa Software Pvt. ltd., Noida, India, 201301
1102, Pacific, xavier urbtech
sector 168
UTTAR PRADESH
201301
India |
| Phone |
07417455107 |
| Fax |
|
| Email |
itra.singh@agatsa.com |
|
|
Source of Monetary or Material Support
|
| Agatsa Software Pvt. Ltd, B-01, sector-59,Noida, Gautam Buddha Nagar, U.P., India; 201301 |
|
|
Primary Sponsor
|
| Name |
Agatsa Software Pvt. Ltd. |
| Address |
B-01, sector 59, Noida, U.P., India; 201301 |
| Type of Sponsor |
Other [Medical Device Manufacturing] |
|
|
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 Surendra Deora |
AIIMS Jodhpur |
Department of Cardiology,Division-cardiology, Room No.- 436, AIIMS, jodhpur, Rajasthan
Jodhpur
RAJASTHAN |
8003996715
drsdeora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trial) AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patient above 18 years, male & female, patients visiting general OPD & Cardiac OPD of AIIMS, Diagnosed with CVD & new cases, Vulnerable group including- elderlies, Economical and social disadvantaged, refuge, migrants, homeless, physically disabled. |
|
| ExclusionCriteria |
| Details |
pregnant lady, lactating mother, children, age less than 18 years, terminally ill, pace maker installed, mentally disabled. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative accuracy analysis of SANKETLIFE PROPLUS. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Applicability of SANKETLIFE PROPLUS at home care. |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
01/02/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [itra.singh@agatsa.com].
- For how long will this data be available start date provided 01-02-2024 and end date provided 01-02-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background- ECG is the most common and widely used imaging tool helping in detecting patients with symptoms compatible with ACS. The problem with the conventional ECG machine is being bulky, it is immobile and cumbersome. The conventional ECG setup requires a trained technologist to operate them correctly. The manual interpretation is often time taking. Presence of artefact interference sometimes is responsible for faulty graph generation. Moreover, these ECG machines require the electrode placement on patient’s body which presents physical discomfort to them.
Recent Research & technology have made taking ECG convenient never before. The latest advancements have led to the making of Touch based ECG devices that has simplified the time consuming process of taking ECG from the cumbersome conventional ECG machine and its manual interpretation. These devices have simplified the process to the extent that even a patient can record his or her own ECG with minimum or no supervision, even at home. These latest ECG devices are touch-based, with instant report in lesser duration. The touch based operation has eliminated the requirement for lead placement. This problem has also been resolved by the AI intervention in these portable ECG devices. The cloud based functioning has enabled the data storage sharing of reports to the cardiologists in any emergency and that is how these latest ECG devices can help a patient with timely diagnosis and interventions.
Purpose- This is an Industry-Faculty driven Single Centre comparative phase 4 (Post-Marketing Surveillance Trial) This trial is being conducted to check the accuracy of Agatsa’s SanketLife Proplus, AI based portable ECG device. This device is key chain size, touch-based leadless and can be converted into lead based setup with the help of detachable switch-sy convertor.
Patient recruitment will be started only after getting CTRI no.
|