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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT04371159
Eligibility Criteria:
Inclusion Criteria:
* Males and Females 18-80 years of age;
* Subjects who are healthy or:
* Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following):
* Urinary tract infection (UTI)
* Patients with suspected or known occult blood in urine
* Pregnant women
* Other relevant conditions
* Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion)
* Subject is capable and willing to provide informed consent;
* Subject has facility with both hands;
* Subject is capable and willing to adhere to the study procedures.
* Subject is familiar with the use of a smartphone
* Subject is capable of comprehending and following instructions in English
Exclusion Criteria:
* Subject has dementia.
* Subject has mental disorders.
* Subject cannot collect urine in a receptacle.
* Subject is visually impaired (cannot read the user manual).
* Any additional reason the study physician believes disqualifies the subject from participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04371159
Study Brief:
Protocol Section:
NCT04371159