NCT03807635

Simulated Clinical Use Testing on Safety Lancets (Test A)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: HTL-Strefa S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance 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 and lay persons.

Conditions

• Needle Stick

Interventions

Type	Name	Description
DEVICE	ergoLance safety lancet	The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
DEVICE	Acti-Lance safety lancet	The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.

Timeline

• Start date: 2018-11-30
• Primary completion: 2018-12-13
• Completion: 2018-12-13
• First posted: 2019-01-17
• Last updated: 2019-01-22

Locations

2 sites across 1 country: United States