Simulated Clinical Use Testing on Safety Lancets (Test A)

Needle Stick Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807635
• Other study ID #: Test A
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: January 2019
• Source: HTL-Strefa S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 13, 2018
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Needle Stick
• Needlestick Injuries

Intervention

Device:
• ergoLance safety lancet
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
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.

Locations

Country	Name	City	State
United States	Schlesinger Associates	Boston	Massachusetts
United States	UL LLC	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
HTL-Strefa S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The true failure rate of the tested devices		At time of testing, up to 90 minutes
Primary	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	Subjective assessments regarding evaluators' interactions with the tested safety lancets	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	Safety of the devices based on the evaluators' assessments (five-point response scale)	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.	At time of testing, up to 90 minutes
Secondary	Various aspects of the ease of use.	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	Any handling, usability questions / issues associated with the device	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