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Randomized Controlled Trial
. 2021 Dec;28(1):1915-1922.
doi: 10.1080/10717544.2021.1976309.

Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system

E Lynne Kelley  1 , Richard H Smith  1 , Gillian Corcoran  1 , Sandra Nygren  1 , Mary V Jacoski  1 , Andrea Fernandes  1
Affiliations
Randomized Controlled Trial

Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system

E Lynne Kelley et al. Drug Deliv. 2021 Dec.

Abstract

Needle-free injection is a desirable goal for many reasons, including reducing pain, anxiety, and eliminating safety risks associated with needle-stick injuries. However, development of a safe, reliable needle-free device optimized for at-home use has been met with many challenges. Portal Instruments Inc. has been developing needle-free medication delivery using a well-designed hand-held device, PRIME, that is safe, intuitive to use, and utilizes advanced electronic control of a focused, high velocity, pressurized liquid injection stream. The PRECISE II human study demonstrated that the PRIME needle-free injection system was safe, well tolerated, and strongly preferred by participants for self-injections over a standard needle and syringe. In addition, the study was able to be completed early for superiority following the success of the pre-defined interim analysis.

Keywords: Needle-free injector; pain; preference; self-injection; subcutaneous injection.

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Conflict of interest statement

E.L.K. is a part-time consultant for Portal Instruments. A.F., G.C., S.N., M.V.J. and R.H.S. are full-time employees of Portal Instruments.

Figures

Figure 1.
Figure 1.
PRIME Device (A), the PRIME Device and Disposable Cartridge (B), and the Injection Process (C).
Figure 2.
Figure 2.
Distribution of VAS Pain Scores (in mm) at 0 minutes, 5 minutes and 10 minutes for Assigned (A) PRIME Needle-free and (B) Prefilled Needle & Syringe Injections.
Figure 3.
Figure 3.
Preference. Response to the question: ‘When comparing the Needle-free Injector to the Prefilled Needle & Syringe, I:’.
Figure 4.
Figure 4.
Ease of Use. Response to the question: ‘When comparing the Needle-free Injector to the Prefilled Needle & Syringe, it is:’.
Figure 5.
Figure 5.
Quality of Life. Response to the questions: ‘If you had to inject yourself on a weekly basis because of a chronic illness, which device would you want your physician to prescribe?’.
Figure 6.
Figure 6.
Medication Adherence. Response to the question: ‘I think the chances that I would take my medication would be:’.
See this image and copyright information in PMC

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