Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Needle Stick Clinical Trial

Official title:

Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03803488
• Other study ID #: CIP v1.0 29JAN2016
• Status: Completed
• Phase: N/A
• Start date: September 28, 2016
• Est. completion date: December 9, 2016

Study information

• Verified date: January 2019
• Source: HTL-Strefa S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A simulated clinical use testing on the DropSafe safety pen needle

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 9, 2016
• Est. primary completion date: December 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Needle Stick
• Needlestick Injuries

Intervention

Device:
• DropSafe safety pen needle

Locations

Country	Name	City	State
United States	NAMSA	Golden Valley	Minnesota
United States	NAMSA	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HTL-Strefa S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ease of use	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)	At time of testing, about an hour
Secondary	Ability to follow the instructions for use	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)	At time of testing, about an hour
Secondary	Ease of understanding the instructions for use	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)	At time of testing, about an hour
Secondary	Problems associated with the device	Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)	At time of testing, about an hour