Simulated Clinical Use Testing On Safety Lancets (Test B) (NCT03811444) | Clinical Trial Compass
CompletedNot Applicable
Simulated Clinical Use Testing On Safety Lancets (Test B)
United States30 participantsStarted 2018-11-30
Plain-language summary
A simulated clinical use testing on the HTL-Strefa's safety lancets
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
* 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.
Exclusion Criteria:
Individuals will be excluded if:
* 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
What they're measuring
1
The true failure rate of the tested devices
Timeframe: At time of testing, up to 90 minutes
2
Effectiveness of the safety lancet's sharps injury prevention features