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Completed

NCT Number: NCT03803488

Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

A simulated clinical use testing on the DropSafe safety pen needle

Completed

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Key information

Conditions

Needle Stick Needlestick Injuries Wounds and Injuries Wounds, Penetrating Wounds, Stab

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NAMSA, Golden Valley, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

DropSafe safety pen needle

Device

Primary outcomes

  1. The true failure rate of DropSafe safety pen needle.

    Time frame: 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 outcomes

  1. Ease of use

    Time frame: 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

    Time frame: 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

    Time frame: At time of testing, about an hour

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

  4. Problems associated with the device

    Time frame: At time of testing, about an hour

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

Sponsors and collaborators

Lead sponsor

HTL-Strefa S.A.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 14, 2019
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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