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Completed

NCT Number: NCT03807635

Simulated Clinical Use Testing on Safety Lancets (Test A)

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

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Key information

Conditions

Needle Stick Needlestick Injuries Wounds and Injuries Wounds, Penetrating Wounds, Stab

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UL LLC, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ergoLance safety lancet

Device

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.

Acti-Lance safety lancet

Device

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.

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. Subjective assessments regarding evaluators' interactions with the tested safety lancets

    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.

  2. Safety of the devices based on the evaluators' assessments (five-point response scale)

    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 any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a "greater than" relationship.

  3. Various aspects of the ease of use.

    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.

  4. Any handling, usability questions / issues associated with the device

    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.

Sponsors and collaborators

Lead sponsor

HTL-Strefa S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2019
Registry last updated
Jan 22, 2019

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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