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

HTL-Strefa

Status: Completed

Conditions: Accident Injury

Treatments: Device: Safety lancet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04933461

Test C

Details and patient eligibility

About

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.

Full description

This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.

The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Simulation of skin pricking by using Medlance Plus

Other group

Description:

Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.

Treatment:

Device: Safety lancet

Simulation of skin pricking by using myLance

Other group

Description:

Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.

Treatment:

Device: Safety lancet