Simulated Clinical Use Testing On Safety Lancets (Test B)
NCT ID: NCT03811444
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
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-11-30
2018-12-13
Brief Summary
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Detailed Description
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The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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simulation of skin pricking type 420
The evaluator simulated the capillary blood sampling with the safety lancet type 420
Haemolance Plus safety lancet
Haemolance Plus safety lancet type 420 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients
simulation of skin pricking type 430
The evaluator simulated the capillary blood sampling with the safety lancet type 430
Prolance safety lancet
Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
simulation of skin pricking type 520
The evaluator simulated the capillary blood sampling with the safety lancet type 520
MediSafe Solo safety lancet
MediSafe Solo safety lancet type 520 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
Interventions
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Haemolance Plus safety lancet
Haemolance Plus safety lancet type 420 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients
Prolance safety lancet
Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
MediSafe Solo safety lancet
MediSafe Solo safety lancet type 520 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
Eligibility Criteria
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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.
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
18 Years
ALL
Yes
Sponsors
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HTL-Strefa S.A.
INDUSTRY
Responsible Party
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Locations
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UL LLC
Chicago, Illinois, United States
Schlesinger Associates
Boston, Massachusetts, United States
Countries
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Other Identifiers
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Test B
Identifier Type: -
Identifier Source: org_study_id
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