Status:
COMPLETED
Simulated Clinical Use Testing On Safety Lancets (Test B)
Lead Sponsor:
HTL-Strefa S.A.
Conditions:
Needle Stick
Eligibility:
All Genders
18+ years
Phase:
NA
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: Haemolance Plus, Prolance and MediSafe Solo in the prevention of NSI and to evaluate the user's opinion with regards to the han...
Eligibility Criteria
Inclusion
- The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
- 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.
Exclusion
- Individuals will be excluded if:
- 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
Key Trial Info
Start Date :
November 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03811444
Start Date
November 30 2018
End Date
December 13 2018
Last Update
January 22 2019
Active Locations (2)
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1
UL LLC
Chicago, Illinois, United States, 60606
2
Schlesinger Associates
Boston, Massachusetts, United States, 02116