Simulated Clinical Use Testing on Safety Lancets (Test A)

Completed · Not applicable

Conditions studied: Needle Stick

In brief

A simulated clinical use testing on the HTL-Strefa's safety lancets

Key facts

Study ID

NCT03807635

Run by

HTL-Strefa S.A.

People needed

20

Starts

2018-11-30

Expected to finish

2018-12-13

Last updated by the study team

2019-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UL LLC — Chicago, Illinois, United States
• Schlesinger Associates — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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