Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)

Completed · Not applicable

Conditions studied: Accident Injury

In brief

A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.

Key facts

Study ID

NCT04933461

Run by

HTL-Strefa S.A.

People needed

20

Starts

2019-09-24

Expected to finish

2019-09-27

Last updated by the study team

2021-06-21

Who can join

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

You may qualify if…

• 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…

• evaluators who do not routinely use safety lancets to collect capillary blood samples,
• evaluators who cannot read, write, and speak English,
• evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
• evaluators who have participated in a product evaluation or marketing study involving safety lancets within the last six months

Where it is running

• Chicago office — Chicago, Illinois, United States
• Boston office — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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