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Microneedle-based ISF Sampling Technique
Sponsor: Ascilion AB
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.
Official title: Clinical Investigation of the PELSA Microneedle-Based Device for Dermal Interstitial Fluid Sampling in Healthy Adults: Assessment of Performance and Safety
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2026-11
Completion Date
2027-02
Last Updated
2026-10-21
Healthy Volunteers
Yes
Conditions
Interventions
PELSA System
The PELSA system is a medical device designed to collect dermal interstitial fluid (dISF) using an array of hollow microneedles and controlled subpressure. The procedure involves applying the microneedle array to the skin, followed by extraction and collection of dISF into a capillary tube. Each participant undergoes one sampling session lasting approximately 15 minutes, during which sampling performance, safety, and tolerability are evaluated.
Locations (1)
Charité - Universitätsmedizin
Berlin, State of Berlin, Germany