A multicenter, double arm clinical study to assess the safety & efficacy of Kardiago a handheld portable digital 10 lead simultaneous 12 channel resting ECG device against the conventional 10 lead simultaneous 12 channel resting ECG device

A multicenter, double arm clinical study to assess the safety & efficacy of Kardiago a handheld portable digital 10 lead simultaneous 12 channel resting ECG device against the conventional 10 lead simultaneous 12 channel resting ECG device - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/11/097616

Enrollment

200

Registered

2025-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

None listed

Interventions

Intervention1: KARDIAGO: Handheld portable 10 lead Simultaneous 12 Channel Resting Digital ECG Intervention2: Nil: Nil Control Intervention1: 12 CHANNEL ECG: APPROVED BY ANY STANDARD USFDA APPROVED DE

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects of age between 18 to 60. 2.For whom the Investigator considers that the compliance will be correct. 3.Cooperating, informed of the need and duration of the study, and ready to comply with protocol procedures. 4.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives. 5. Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure, with pacemaker implants can be included.

Exclusion criteria

Exclusion criteria: 1.Known sensitivity to the investigational product.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study would be the efficacy of the IP which will be assessed by assessing the ECG results from Investigational Product and comparative productTimepoint: VISIT 2	—

Secondary

Measure	Time frame
The Secondary end-points of this study would be safety and adverse eventsTimepoint: VISIT 2	—

Countries

India

Contacts

Public ContactPrathap Vasu C

Nanites Life Sciences Pvt ltd

suresh@naniteslifesciences.com9789606864

Outcome results