Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

NCT03803488 | Completed

• 1 other identifier: CIP v1.0 29JAN2016
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

A simulated clinical use testing on the DropSafe safety pen needle

Conditions

Needle Stick

Keywords

needlestick; needlestick injury; pen needle; sharps injury prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of testing, about an hour

Secondary Outcomes (4)

• Ease of use

  At time of testing, about an hour

• Ability to follow the instructions for use

  At time of testing, about an hour

• Ease of understanding the instructions for use

  At time of testing, about an hour

• Problems associated with the device

  At time of testing, about an hour

Study Arms (1)

simulation of injection

EXPERIMENTAL

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

Device: DropSafe safety pen needle

Interventions

DropSafe safety pen needle DEVICE

simulation of injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• HTL-Strefa S.A.: lead

Study Sites (2)

NAMSA

Golden Valley, Minnesota, 55422, United States

Location

NAMSA

Minneapolis, Minnesota, 55426, United States

Location

MeSH Terms

Conditions

Needlestick Injuries

Condition Hierarchy (Ancestors)

Wounds, Stab; Wounds, Penetrating; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 14, 2019
• Study Start: September 28, 2016
• Primary Completion: December 9, 2016
• Study Completion: December 9, 2016
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

US (2)