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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT04391257
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged ≥ 18 years and able to provide written informed consent.
* Intact healthy skin at the site of geko™ device application.
* Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.
* Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion Criteria:
* Pregnancy or breast feeding.
* Use of any concurrent use of a neuro-modulation device.
* Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)
* Participation in any other clinical study that may interfere with the outcome of either study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04391257
Study Brief:
Protocol Section:
NCT04391257