Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT04933461
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
Sponsor:
HTL-Strefa S.A.
Organization:
Study Overview
Official Title:
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: