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

A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.

Study Overview

• Status: Completed
• Conditions: Accident Injury
• Intervention / Treatment: Device: Safety lancet

Detailed Description

This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.

The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.

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

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60606
      • Chicago office
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Boston office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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:

• evaluators who do not routinely use safety lancets to collect capillary blood samples,
• evaluators who cannot read, write, and speak English,
• evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
• evaluators who 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
Other: Simulation of skin pricking by using Medlance Plus; Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.	Device: Safety lancet; There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
Other: Simulation of skin pricking by using myLance; Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.	Device: Safety lancet; There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.

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	Time Frame
Evaluation of the safety of the devices based on the evaluators' assessments.	At time of testing, up to 90 minutes ]
Evaluation of various aspects of the ease of use.	At time of testing, up to 90 minutes ]
Detection of any handling, usability questions / issues associated with the device.	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): September 24, 2019
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): September 27, 2019

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: capillary blood sampling; safety lancet; accidental needle-stick injury
• Additional Relevant MeSH Terms: Wounds, Stab; Wounds, Penetrating; Wounds and Injuries; Needlestick Injuries; Accidental Injuries
• Other Study ID Numbers: Test C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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