Clinical Performance Testing of ECG Machine of Kavitul Technologies Pvt. Ltd.

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 - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073885

Enrollment

100

Registered

2024-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I999- Unspecified disorder of circulatory system

Interventions

Intervention1: 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 e

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 machineTimepoint: 2 minutes	—

Secondary

Measure	Time frame
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 parametersTimepoint: 2 minutes	—

Measure

Time frame

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 parametersTimepoint: 2 minutes

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Countries

India

Contacts

Public ContactMr Ajinkya Puranik

Parul Sevashram Hospital

jigneshkumar.patel24313@paruluniversity.ac.in9978067027

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026