This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
20
Experimental device.
HMC standard of care.
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Adverse events
No device-attributable adverse events.
Time frame: Up to 8 days
Pain Response
Pain level at specified study intervals measured on Neonatal Facial Coding System (NFCS) scale
Time frame: 2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure
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