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:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT06003205
Eligibility Criteria:
Inclusion Criteria:
* 18 to 50 years of age, at the time of signing the informed consent
* Overtly healthy as determined by medical evaluation including medical history, physical examination and focused cardiac ultrasound.
* Use of adequate birth control for women of childbearing potential. Inclusion is possible when an acceptable effective contraceptive measure is used (combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
* Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
* Breached skin at patch mounting area.
* Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.
* Planned magnetic resonance (MR) imaging during the investigation period
* Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).
* Pregnancy
* Breastfeeding
* History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).
* Any known cardiac disease that, at the investigator's discretion, warrants exclusion from the study, including but not limited to cardiac arrhythmia, esophageal varices, and aneurysms.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06003205
Study Brief:
Protocol Section:
NCT06003205