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)

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

Study Overview

• Status: Completed
• Conditions: Needle Stick
• Intervention / Treatment: Device: ergoLance safety lancet; Device: Acti-Lance safety lancet

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60606
      • UL LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Schlesinger Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: simulation of skin pricking type 450; The evaluator simulated the capillary blood sampling with the safety lancet type 450	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.
Experimental: simulation of skin pricking type 610; The evaluator simulated the capillary blood sampling with the safety lancet type 610	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	At time of testing, up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective assessments regarding evaluators' interactions with the tested safety lancets	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.	At time of testing, up to 90 minutes
Safety of the devices based on the evaluators' assessments (five-point response scale)	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.	At time of testing, up to 90 minutes
Various aspects of the ease of use.	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.	At time of testing, up to 90 minutes
Any handling, usability questions / issues associated with the device	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.	At time of testing, up to 90 minutes

Collaborators and Investigators

• Sponsor: HTL-Strefa S.A.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): December 13, 2018
• Study Completion (Actual): December 13, 2018

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: capillary blood sampling; needlestick; needlestick injury; sharps injury prevention; safety lancet
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Stab; Wounds, Penetrating; Needlestick Injuries
• Other Study ID Numbers: Test A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No