This is a device feasibility study designed to evaluate the practicality of delivering a high-viscosity solution subcutaneously using various injection parameters, including volume, rate, and needle length. The goal is to assess the usability and operational performance of a delivery setup (Havard apparatus syringe pump and related components) to inform design requirements for future large-volume injection devices. No active drug is administered in this study, and no health outcomes are being evaluated. The study duration is approximately 40 days, including screening, injection assessments, and follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
32
Used to administer buffer solution with hyaluronic acid SC.
Fortrea CRU, Inc.
Dallas, Texas, United States
Usability Assessment of Subcutaneous Injections Using a Syringe Pump Across Multiple Delivery Parameters
Usability will be assessed by evaluating the proportion of subcutaneous injections administered using Harvard Apparatus syringe pump across varying injection volumes, rates, and needle lengths.
Time frame: Day 1
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