| CTRI Number |
CTRI/2024/09/073885 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Clinical Performance Testing of ECG Machine of Kavitul Technologies Pvt. Ltd. |
|
Scientific Title of Study
|
Clinical Performance Testing of ECG Machine named Dr Cardio of Kavitul Technologies Pvt Ltd in comparison with already approved ECG Machine being use at the Participating Hospital Site |
| 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 Sanket Saraiya |
| Designation |
Principal Investigator |
| Affiliation |
Parul Sevashram Hospital |
| Address |
Parul Sevashram Hospital,
Parul University, Waghodia Road, P.O.Limda,
Ta.Waghodia
Clinical Research Department
No. 231 (new), Near Delux Ward, 2nd Floor,
Parul Sevashram Hospital,
Parul University Campus, Waghodia Road, P.O.Limda,
Ta.Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
|
| Email |
cr.psh@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jignesh Patel |
| Designation |
Head: Clinical Research |
| Affiliation |
Parul Sevashram Hospital |
| Address |
Clinical Research Department
No. 231 (new), Near Delux Ward, 2nd Floor,
Parul Sevashram Hospital,
Parul University Campus, Waghodia Road, P.O.Limda,
Ta.Waghodia
Clinical Research Department
No. 231 (new), Near Delux Ward, 2nd Floor,
Parul Sevashram Hospital,
Parul University Campus, Waghodia Road, P.O.Limda,
Ta.Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9978067027 |
| Fax |
|
| Email |
jigneshkumar.patel24313@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ajinkya Puranik |
| Designation |
Director |
| Affiliation |
Kavitul Technologies Pvt. Ltd. |
| Address |
A-404, Sunrise Point, Raopura, Vadodara,
Gujarat, India-390001.
A-404, Sunrise Point, Raopura, Vadodara,
Gujarat, India-390001.
Vadodara
GUJARAT
390001
India |
| Phone |
9624639089 |
| Fax |
|
| Email |
ajinkya@kavitul.com |
|
|
Source of Monetary or Material Support
|
| Kavitul Technologies Pvt. Ltd.
A-404, Sunrise Point, Raopura, Vadodara, Gujarat, India-390001. |
|
|
Primary Sponsor
|
| Name |
Kavitul Technologies Pvt. Ltd. |
| Address |
A-404, Sunrise Point, Raopura, Vadodara, Gujarat, India-390001. |
| 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 Priyanshi Shah |
Parul Sevashram Hospital |
Room no. 231, 2nd Floor, Near Delux Ward, Parul Sevashram Hospital, Near Parul University Campus, Waghodia Road, P.O.Limda,
Ta.Waghodia – 391760
Vadodara
GUJARAT |
9998981360
cr.psh@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University – Institutional Ethics Committee for Human Research (PU-IECHR) |
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 |
BPL Cardioart-9108 |
“BPL Cardioart-9108†is designed by BPL Ltd. It is approved ECG machine that operates all 12 channels simultaneously. The complete ECG machine kit comes with chest electrodes, clamp electrodes, ECG cable, and the ECG machine device. The ECG machine works on the power supplied and it is already approved and currently being used at many hospitals and clinics in India.
Total duration of intervention: One time for capturing only ECG with each group |
| Intervention |
Dr. Cardio ECG Machine |
“Dr. Cardio†is designed by Kavitul Technologies Pvt. Ltd. It is small sized, light weight ECG machine that operates all 12 channels simultaneously. It can be easily connected to any Android system device through Bluetooth wireless connection and the report is released in the form of a PDF file. The complete ECG machine kit comes with chest electrodes, clamp electrodes, ECG cable, and the ECG machine device. To operate the ECG machine, the user needs to download and install Dr. Cardio app in any Android system device, needs switch on Bluetooth and needs to connect via Bluetooth. The ECG machine works on the power supplied from internal rechargeable battery, which can be charged whenever required. It is currently being used at many hospitals and clinics in India.
Total duration of intervention: One time for capturing only ECG with each group |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Any healthy subject who voluntarily ready to undergo electrocardiography or any patients who voluntarily ready to undergo electrocardiography
2. Any volunteer who gives informed consent to participate in this study |
|
| ExclusionCriteria |
| Details |
1. Critically ill and clinically unstable patient who may not be comfortable to undergo electrocardiography
2. Patient having any psychological illness which may compromise the patient’s compliance / co-operation for electrocardiography
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To compare performance of test ECG machine with reference ECG machine by comparing manually measured values of Heart Rate (HR), R wave amplitude and intervals like RR, PR, QRS, QTc, QT/QTc ratio
2) To compare physician’s overall ease of reviewing the ECG waveforms captured using test ECG machine vs reference ECG machine |
2 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare number of errors happening with test ECG machine vs reference ECG machine
2) To study user’s convenience with the test ECG machine and to compare it with reference ECG machine
3) To study subject’s convenience of undergoing electrocardiography with the test ECG machine and to compare it with reference ECG machine
4) To study the safety of the subject undergoing electrocardiography using the test ECG machine and to compare it with reference ECG machine
5) To study the clinical performance of test ECG machine in terms of automatic measuring the Heart Rate (HR), R wave amplitude and intervals like RR, PR, QRS, QT, QTc, QT/QTc ratio (whichever is available on ECG print) by comparing with manually measured values of these parameters |
2 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
24/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/12/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Following procedures will be carried out during screening on or withing 28 days before of enrolment in the study. · Written informed consent will be taken from the subject. No study related procedure will be conducted prior to obtaining written informed consent. · Assessment of subject eligibility as per Inclusion and Exclusion criteria. STUDY PROCEDURES (DAY 1) Following procedures will be carried out as a part of study. · Evaluation as per inclusion/exclusion criteria (if subject has undergone evaluation as per inclusion/exclusion criteria on day 1 as a part of screening, then same evaluation again on day 1 as a part of study procedure will not be required) · Demographics (Age, Gender, Ethnicity and Race only) data capture · Capturing Medication and Medical history · Randomization · Electrocardiography with both the ECG machine one by one as per randomization sequence · Monitoring and capturing of AE/SAE (if any) · Clinical Performance Variable Evaluation
|