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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT03807635
Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
* (HCP evaluators only) - evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
* evaluators will be United States (US) residents
* evaluators can read, write, and speak English
* evaluators are at least 18 years old
* evaluators are able to understand and provide signed consent for the study
* evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
* evaluators have no concerns about the ability to perform the simulated skin pricking.
Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.
Exclusion Criteria:
HCPs:
* They do not routinely use safety lancets to collect capillary blood samples,
* They cannot read, write, and speak English,
* They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
* They have participated in a product evaluation or marketing study involving safety lancets within the last six months
Lay people:
* They cannot read, write, and speak English,
* They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
* They have participated in a product evaluation or marketing study involving safety lancets within the last six months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03807635
Study Brief:
Protocol Section:
NCT03807635