Simulated Clinical Use Testing on Safety Lancets (Test A)

Not Applicable

Completed

• Conditions: Needle Stick
• Interventions: Device: Acti-Lance safety lancet; Device: ergoLance safety lancet

• Registration Number: NCT03807635
• Lead Sponsor: HTL-Strefa S.A.

Brief 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.

Study Timeline

• Study Start: 2018-11-30
• Primary Completion: 2018-12-13
• Study Completion: 2018-12-13
• Status Verified: 2019-01
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:

• (HCP evaluators only) - 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.

Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.

Exclusion Criteria

HCPs:

• 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 or marketing study involving safety lancets within the last six months

Lay people:

• 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 or marketing study involving safety lancets within the last six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
simulation of skin pricking type 610	Acti-Lance safety lancet	The evaluator simulated the capillary blood sampling with the safety lancet type 610
simulation of skin pricking type 450	ergoLance safety lancet	The evaluator simulated the capillary blood sampling with the safety lancet type 450

Primary Outcome Measures

Name	Time	Method
The true failure rate of the tested devices	At time of testing, up to 90 minutes
Effectiveness of the safety lancet's sharps injury prevention features	At time of testing, up to 90 minutes	Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.

Secondary Outcome Measures

Name	Time	Method
Subjective assessments regarding evaluators' interactions with the tested safety lancets	At time of testing, up to 90 minutes	Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
Safety of the devices based on the evaluators' assessments (five-point response scale)	At time of testing, up to 90 minutes	Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a "greater than" relationship.
Various aspects of the ease of use.	At time of testing, up to 90 minutes	Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
Any handling, usability questions / issues associated with the device	At time of testing, up to 90 minutes	Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.

Trial Locations

Locations (2)

UL LLC; 🇺🇸 Chicago, Illinois, United States

Schlesinger Associates; 🇺🇸 Boston, Massachusetts, United States