Trials / Completed
CompletedNCT04933461
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- HTL-Strefa S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices. The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Safety lancet | There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients. |
Timeline
- Start date
- 2019-09-24
- Primary completion
- 2019-09-24
- Completion
- 2019-09-27
- First posted
- 2021-06-21
- Last updated
- 2021-06-21
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04933461. Inclusion in this directory is not an endorsement.