Simulated Clinical Use Testing on Safety Lancets (Test A)
NCT ID: NCT03807635
Last Updated: 2019-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2018-11-30
2018-12-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Simulated Clinical Use Testing On Safety Lancets (Test B)
NCT03811444
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
NCT04933461
Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
NCT03803488
Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
NCT01148706
Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges
NCT02663635
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples and lay persons.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
simulation of skin pricking type 450
The evaluator simulated the capillary blood sampling with the safety lancet type 450
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.
simulation of skin pricking type 610
The evaluator simulated the capillary blood sampling with the safety lancet type 610
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HTL-Strefa S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UL LLC
Chicago, Illinois, United States
Schlesinger Associates
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Test A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.