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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT01590368
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent
* Be a healthy volunteer and be over 18 years of age
* Willing to attend two scheduled visits for application and removal of the device and adverse event review
* Have healthy unbroken skin
Exclusion Criteria:
* Subjects with a history of sensitivity to any one of the components of the device being studied
* Subjects who have a history of skin related disorders to the chest.
* Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
* Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01590368
Study Brief:
Protocol Section:
NCT01590368