Simulated Clinical Use Testing On Safety Lancets (Test B)

HTL-Strefa

Status: Completed

Conditions: Needle Stick

Treatments: Device: MediSafe Solo safety lancet; Device: Prolance safety lancet; Device: Haemolance Plus safety lancet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03811444

Test B

Details and patient eligibility

About

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

Full description

This study aims to evaluate the safety of the use of the safety lancets: Haemolance Plus, Prolance and MediSafe Solo in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices.

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

simulation of skin pricking type 420

Experimental group

Description:

The evaluator simulated the capillary blood sampling with the safety lancet type 420

Treatment:

Device: Haemolance Plus safety lancet

simulation of skin pricking type 430

Experimental group

Description:

The evaluator simulated the capillary blood sampling with the safety lancet type 430

Treatment:

Device: Prolance safety lancet

simulation of skin pricking type 520

Experimental group

Description:

The evaluator simulated the capillary blood sampling with the safety lancet type 520

Treatment:

Device: MediSafe Solo safety lancet