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Completed

NCT Number: NCT04933461

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.

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Key information

Conditions

Accident Injury Accidental Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chicago office, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safety lancet

Device

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

Primary outcomes

  1. The true failure rate of the tested devices.

    Time frame: At time of testing, up to 90 minutes

  2. Effectiveness of the safety lancet's sharps injury prevention features.

    Time frame: 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 outcomes

  1. Evaluation of the safety of the devices based on the evaluators' assessments.

    Time frame: At time of testing, up to 90 minutes ]

  2. Evaluation of various aspects of the ease of use.

    Time frame: At time of testing, up to 90 minutes ]

  3. Detection of any handling, usability questions / issues associated with the device.

    Time frame: At time of testing, up to 90 minutes ]

Sponsors and collaborators

Lead sponsor

HTL-Strefa S.A.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2021
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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