A multicenter, double arm clinical study to assess the safety & efficacy of CardioSAM ECGagainst the conventional 12 channel ECG
Not Applicable
- Conditions
- Health Condition 1: Z018- Encounter for other specified special examinations
- Registration Number
- CTRI/2021/03/032160
- Lead Sponsor
- Samtech Devices India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Exclusion Criteria
1.Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.
2.Known sensitivity to the investigational product
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>The primary endpoint of the study would be the efficacy of the IP which will be <br/ ><br>assessed by assessing the ECG results from Investigational Product and <br/ ><br>comparative productTimepoint: <br/ ><br>The primary endpoint of the study would be the efficacy of the IP which will be <br/ ><br>assessed by assessing the ECG results from Investigational Product and <br/ ><br>comparative product on vist 2
- Secondary Outcome Measures
Name Time Method The Secondary end-points of this study would be safety and adverse eventsTimepoint: Visit 2