Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT05591157
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 21 years old
* Able and willing to understand and sign the informed consent and follow instructions
* Screening ECG results of Sinus Rhythm
* Wrist size 14 cm (5.5"), Max 20 cm (7.8")
Exclusion Criteria:
* Subjects who are currently enrolled in other clinical investigation
* Subjects diagnosed with a cardiac disorder or any cardiac symptoms
* Subjects with SNR \< 100
* Subjects with ECG quality range \> 1 and \< 30
* Individuals with electrical pacing by a pacemaker
* Subjects who are pregnant or breastfeeding
* Subjects with callous on the index finger or thumb (at fingerprint area)
* Subjects with active wound, prior soft tissue injury or skin conditions at the measurement location Sensitivity to the device material or ECG patches
* Subjects with tremors or otherwise unable to remain still for 15 minutes
* Subjects without two hands and sufficient fingers to complete the study
* Subjects unable to participate based upon investigator discretion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05591157
Study Brief:
Protocol Section:
NCT05591157