Simulated Clinical Use Testing on Safety Lancets (Test A)

• ClinicalTrials.gov Identifier: NCT03807635
• Recruitment Status: Completed
• First Posted: January 17, 2019
• Last Update Posted: January 22, 2019
• Sponsor: HTL-Strefa S.A.
• Information provided by (Responsible Party): HTL-Strefa S.A.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Needle Stick	Device: ergoLance safety lancet; Device: Acti-Lance safety lancet	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)
• Actual Study Start Date: November 30, 2018
• Actual Primary Completion Date: December 13, 2018
• Actual Study Completion Date: December 13, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: simulation of skin pricking type 450; The evaluator simulated the capillary blood sampling with the safety lancet type 450	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.
Experimental: simulation of skin pricking type 610; The evaluator simulated the capillary blood sampling with the safety lancet type 610	Device: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Illinois

UL LLC

Chicago, Illinois, United States, 60606

United States, Massachusetts

Schlesinger Associates

Boston, Massachusetts, United States, 02116

Sponsors and Collaborators

HTL-Strefa S.A.

More Information

• Responsible Party: HTL-Strefa S.A.
• ClinicalTrials.gov Identifier: NCT03807635
• Other Study ID Numbers: Test A
• First Posted: January 17, 2019
• Last Update Posted: January 22, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by HTL-Strefa S.A.:

needlestick; needlestick injury; safety lancet; sharps injury prevention; capillary blood sampling

Additional relevant MeSH terms:

Needlestick Injuries; Wounds, Stab; Wounds, Penetrating; Wounds and Injuries