Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

HTL-Strefa S.A.35 enrolled

Overview

A simulated clinical use testing on the DropSafe safety pen needle

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Needle Stick

Interventions

DropSafe safety pen needleDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

NAMSA

Golden Valley, Minnesota, United States

NAMSA

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

The true failure rate of DropSafe safety pen needle.

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.