Simulated Clinical Use Testing On Safety Lancets (Test B)

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

NCT03811444

Run by

HTL-Strefa S.A.

People needed

30

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:
• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.