Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Not Applicable

Completed

• Conditions: Needle Stick
• Interventions: Device: DropSafe safety pen needle

• Registration Number: NCT03803488
• Lead Sponsor: HTL-Strefa S.A.

Brief Summary

A simulated clinical use testing on the DropSafe safety pen needle

Detailed Description

This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.

Study Timeline

• Study Start: 2016-09-28
• Primary Completion: 2016-12-09
• Study Completion: 2016-12-09
• Status Verified: 2019-01
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Study First Posted: 2019-01-14
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Minimum of age 18.
2. Able to understand and provide signed consent for the study.
3. Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
4. Have no concerns about the ability to perform the simulated injections.
5. Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).

Exclusion Criteria

1. If in the opinion of the sponsor or MRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for reasons such as mental health.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
simulation of injection	DropSafe safety pen needle	The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.

Primary Outcome Measures

Name	Time	Method
The true failure rate of DropSafe safety pen needle.	At time of testing, about an hour	The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature.

Secondary Outcome Measures

Name	Time	Method
Ease of use	At time of testing, about an hour	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Ease of understanding the instructions for use	At time of testing, about an hour	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Problems associated with the device	At time of testing, about an hour	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Ability to follow the instructions for use	At time of testing, about an hour	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)

Trial Locations

Locations (1)

NAMSA; 🇺🇸 Minneapolis, Minnesota, United States