NCT03811444

Simulated Clinical Use Testing On Safety Lancets (Test B)

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: 30 (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: 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.

Conditions

• Needle Stick

Interventions

Type	Name	Description
DEVICE	Haemolance Plus safety lancet	Haemolance Plus safety lancet type 420 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients
DEVICE	Prolance safety lancet	Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
DEVICE	MediSafe Solo safety lancet	MediSafe Solo safety lancet type 520 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.

Timeline

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

Locations

2 sites across 1 country: United States