Clinical trial NCT03807635: Simulated Clinical Use Testing on Safety Lancets (Test A)
Official title: Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needle Stick
Keywords: needlestick
needlestick injury
safety lancet
sharps injury prevention
capillary blood sampling
Lead sponsor: HTL-Strefa S.A.
Sponsor class: INDUSTRY
First posted: 2019-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility 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

Primary outcomes:
measure: The true failure rate of the tested devices
timeFrame: At time of testing, up to 90 minutes
measure: Effectiveness of the safety lancet's sharps injury prevention features
timeFrame: At time of testing, up to 90 minutes
Secondary outcomes:
measure: Subjective assessments regarding evaluators' interactions with the tested safety lancets
timeFrame: At time of testing, up to 90 minutes
measure: Safety of the devices based on the evaluators' assessments (five-point response scale)
timeFrame: At time of testing, up to 90 minutes
measure: Various aspects of the ease of use.
timeFrame: At time of testing, up to 90 minutes
measure: Any handling, usability questions / issues associated with the device
timeFrame: At time of testing, up to 90 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UL LLC
state: Illinois
city: Boston
country: United States
facility: Schlesinger Associates
state: Massachusetts
Study officials:
References: