Effects of DigiVibe on Pain in Subjects Undergoing Intramuscular Injections, Subcutaneous Injections, and Fingersticks

This is a single-center, unblinded, prospective, cross-over study. The study population will include twenty (n=20) healthy subjects (10 men and 10 women) over the age of 18 with a self-reported fear/dislike of needles. Subjects who qualify for the study based on the study inclusion and exclusion criteria and who consent to participate in the study will undergo two (2) intramuscular (IM) injections in the deltoid muscle, two (2) subcutaneous (SC) injections in the abdomen, and two (2) fingersticks with a lancing device in the middle finger. One injection in each location will be performed using with no intervention (as per standard of care) and the other injection in each location will be performed using the DigiVibe device.

NCT Number	NCT06987201
Lead Sponsor	East Coast Institute for Research Collaborators: Universal Axon Clinical Research, LLC, Suthe Dermal
Conditions	Healthy
Enrollment	20 participants
Start Date	2025-08-04
Primary Completion	2025-08-15 (estimated)
Study Completion	2025-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-14