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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-24

Study Completion Date

2019-09-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Accident Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Safety lancet

Intervention Type DEVICE

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

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.

Group Type OTHER

Safety lancet

Intervention Type DEVICE

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

Interventions

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Safety lancet

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes