Simulated Clinical Use Testing On Safety Lancets (Test B)

HTL-Strefa S.A.30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Needle Stick

Interventions

Haemolance Plus safety lancetDEVICE

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

Prolance safety lancetDEVICE

Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.

MediSafe Solo safety lancetDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

UL LLC

Chicago, Illinois, United States

Schlesinger Associates

Boston, Massachusetts, United States