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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04933461

Enrollment

Registered

2021-06-21

Start date

2019-09-24

Completion date

2019-09-27

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accident Injury

Keywords

safety lancet, capillary blood sampling, accidental needle-stick injury

Brief summary

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.

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.

Interventions

DEVICESafety lancet

There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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 ]

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026