Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

• Sponsor: HTL-Strefa S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03803488
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Arm: 1
• Actual Duration (Months): 2.4
• Patients Per Site: 17.5
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

A simulated clinical use testing on the DropSafe safety pen needle

Condition or Disease	Intervention/Treatment	Phase
Needle Stick	Device: DropSafe safety pen needle	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
• Actual Study Start Date: Sep 28, 2016
• Actual Primary Completion Date: Dec 9, 2016
• Actual Study Completion Date: Dec 9, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: simulation of injection 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

Outcome Measures

Primary Outcome Measures

1. 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

1. Ease of use [At time of testing, about an hour]

   Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)

2. 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)

3. 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)

4. Problems associated with the device [At time of testing, about an hour]

   Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NAMSA	Golden Valley	Minnesota	United States	55422
2	NAMSA	Minneapolis	Minnesota	United States	55426

Sponsors and Collaborators

• HTL-Strefa S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HTL-Strefa S.A.
• ClinicalTrials.gov Identifier: NCT03803488
• Other Study ID Numbers: CIP v1.0 29JAN2016
• First Posted: Jan 14, 2019
• Last Update Posted: Jan 14, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by HTL-Strefa S.A.: needlestick; needlestick injury; pen needle; sharps injury prevention
• Additional relevant MeSH terms: Needlestick Injuries

Study Results

No Results Posted as of Jan 14, 2019