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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT02426593
Eligibility Criteria:
Inclusion Criteria:
* Subjects \> 30 years of age
* Subjects who are ambulatory not requiring assistance for ambulation
* Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB
Exclusion Criteria:
* Subjects with an active implantable medical device not cleared for use with the IMED-4 in the IMED- 4 Investigators Brochure.
* Subjects who are pregnant or lactating or who have been pregnant within the past three months
* Subjects who have a measured temperature of \>38° C at the time of screening
* Subjects who have tattoos and/or non-intact skin on the back in the electrode patch placement region
* Subjects who have had a past serious allergic reaction to adhesives
* Patients who decline to have their backs photographed with the IMED-4 device in position
* Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectance, etc.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT02426593
Study Brief:
Protocol Section:
NCT02426593