Microneedle-based ISF Sampling Technique

Brief Summary

This clinical investigation aims to evaluate the performance and safety of the PELSA system, a hollow microneedle-based medical device designed for the collection of dermal interstitial fluid (dISF) from human skin. Healthy adult volunteers will undergo a single dISF sampling session using the PELSA system. The primary objective is to assess the proportion of participants from whom at least 1 µL of dISF can be successfully collected during one sampling session. Device safety and tolerability will also be evaluated, including the occurrence of adverse events, participant-reported pain, and local skin reactions. Exploratory assessments may include glucose detection and proteomic analysis of collected dISF samples.