ECG device validation

To validate the accuracy of Cicer (a non-invasive electrocardiography device) against a reference 12-Lead ECG device (FDA/CE marked) in healthy volunteers and individuals with a medical condition

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021814

Enrollment

Registered

2019-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Control Intervention1: Cicer electrocardiography device: 12-Lead ECG device (FDA/CE marked) Control Intervention2: 12-Lead ECG device (FDA/CE marked): Total duration: one day

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female subjects. 2. Age above 18 years. 3. Willingness to participate after providing informed consent.

Exclusion criteria

Exclusion criteria: 1. Female patients who are pregnant or lactating. 2. Patients with pacemaker implantation 3. Patients suffering from cardio-respiratory, neurological or endocrinal disorders or any other condition whatsoever, which in judgement of the Investigator deemed unfit for the study inclusion as evident from the medical history/concurrent illness(s). 4. Patients based on abnormal rhythms as evident by the current ECG and medical history/concurrent illness(s). 5. Medical or surgical indication that might prevent use of ECG. 6. Patients who have completed participation in any other clinical trial during the past six (06) months. 7. Patients on mechanical ventilation

Design outcomes

Primary

Measure	Time frame
To validate the accuracy of Cicer, a non-invasive electrocardiography device, in comparison to reference 12-Lead ECG (FDA/CE marked device) in healthy and individuals with a medical condition, as per the standards of ANSI/AAMI/ISO 14155:2011.Timepoint: One day	—

Secondary

Measure	Time frame
Validation of Cicer non-invasive electrocardiography deviceTimepoint: one day	—

Countries

India

Contacts

Public ContactMrPrasad Bhat

Ten3T Healthcare Pvt Ltd

sudhir@ten3thealth.com

Outcome results