Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
NCT04933461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-06-21
Summary
A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.
Conditions
- Accident Injury
Interventions
- DEVICE
-
Safety lancet
There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
Sponsors & Collaborators
-
HTL-Strefa S.A.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-09-24
- Primary Completion
- 2019-09-24
- Completion
- 2019-09-27
Countries
- United States
Study Locations
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