An interventional study of PELSA System in No Condition, Healthy Individuals, sponsored by Ascilion AB. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ascilion AB · Not applicable, Interventional, and Other
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.
Ascilion AB is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo one dermal interstitial fluid sampling session using the PELSA system. The device employs an array of hollow microneedles and controlled subpressure to collect dermal interstitial fluid from the skin. Sampling performance, safety, and participant tolerability will be assessed.
Device: 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.
Also known as: PELSA, Hollow Microneedle Sampling System
Successful Collection of Dermal Interstitial Fluid
Proportion of participants with successful collection of at least 1 µL of dermal interstitial fluid during one PELSA sampling session. The success proportion and its 95% confidence interval will be calculated.
Time frame: During the sampling session
Incidence of Device-Related Serious Adverse Events
Number and proportion of participants experiencing device-related serious adverse events during the investigation and follow-up period.
Time frame: From device application through 7-day follow-up.
Participant-Reported Pain During PELSA Sampling
Procedural pain will be assessed using a participant-reported Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be summarized descriptively across participants.
Time frame: During and immediately after the sampling procedure (Day 1).
Local Skin Reactions Following PELSA Sampling
Standardized photographs of the sampling site will be obtained after the PELSA procedure to document visible skin changes, including erythema, bleeding, or other local reactions. Skin findings will be evaluated descriptively.
Time frame: Before and after the sampling procedure (Day 1).
Detectability of Glucose in Collected Dermal Interstitial Fluid
The presence of glucose in collected dermal interstitial fluid (dISF) will be assessed using a commercially available glucose measurement system (Contour Next). The proportion of samples yielding a measurable glucose result will be reported descriptively.
Time frame: Following dISF collection during the study visit (Day 1).
Exploratory Detection of Inflammatory Proteins in Dermal Interstitial Fluid
A subset of 20 collected dISF samples will undergo exploratory proteomic analysis using the NULISA Inflammatory 250 panel. The analysis will assess the detectability of inflammatory proteins in dISF, including the number and proportion of protein targets detected above the assay-specific detection threshold. Results will be summarized descriptively.
Time frame: Samples collected during the study visit (Day 1), with subsequent laboratory analysis.
Plan to share: No — Individual participant data (IPD) will not be made publicly available. Study data will be collected, processed, and retained by the Sponsor and authorized study personnel in accordance with the study protocol, informed consent, and applicable data protection regulations. Aggregated study results may be disseminated through ClinicalTrials.gov, scientific publications, and regulatory reporting.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ascilion AB