Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

HTL-Strefa

Status: Completed

Conditions: Needle Stick

Treatments: Device: DropSafe safety pen needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03803488

CIP v1.0 29JAN2016

Details and patient eligibility

About

A simulated clinical use testing on the DropSafe safety pen needle

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

simulation of injection

Experimental group

Description:

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

Treatment:

Device: DropSafe safety pen needle