No Condition, Healthy IndividualsMISTNCT07882225
Microneedle-based ISF Sampling Technique
A study testing PELSA System in people with No Condition, Healthy Individuals, run by Ascilion AB at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition, Healthy Individuals
- What is being tested?
- PELSA System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years of age (inclusive) at the time of ICF signature.
- Participant is willing to participate and is capable of giving informed consent.
- Participants must understand and sign the informed consent form, be able to comply with all study procedures and must be available for the duration of the study
Who cannot join
- Known dermatologic condition at the site of measurement, including active skin injury, lesion, infection or other dermatologic condition
- Pregnant or breastfeeding persons
- The participant has recently taken NSAIDS (within 72 hours of screening), Aspirin (5 days), prescription anticoagulants (e.g. warfarin, 5 days), or P2Y12 antiplatelet therapies (1 week)
- Vulnerable persons
- On persons with an open wound in or near the sampling area.
- On persons with any type of tattoo or piercing anywhere in or near the sampling area.
- On acral skin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Charité - Universitätsmedizin
Berlin, State of Berlin, 12203
Dr. Carolina Elisa Vera Ayala, +49 30 450 618427, carolina.vera@charite.de
study-coordination-ifa@charite.de
About this study
Official title: Clinical Investigation of the PELSA Microneedle-Based Device for Dermal Interstitial Fluid Sampling in Healthy Adults: Assessment of Performance and Safety
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.
- Conditions
- No Condition, Healthy Individuals
- Being tested
- PELSA System
- Keywords
- Ascilion AB, PELSA, dISF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PELSA SystemDevice
Also called PELSA, Hollow Microneedle Sampling 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.
| Study group | Role | What they receive |
|---|---|---|
| PELSA Dermal Interstitial Fluid Sampling | Experimental | 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. Receives: Device: PELSA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the sampling session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Condition, Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascilion AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Markus Magerl, MD, Ph.D., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882225
- Sponsor's protocol ID
- PD01-CLI-019
- Acronym
- MIST
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the PELSA Microneedle-Based Device for Dermal Interstitial Fluid Sampling in Healthy Adults: Assessment of Performance and Safety
- ClinicalTrials.gov ID
- NCT07882225
- Acronym / sponsor ID
- MIST / PD01-CLI-019
- Conditions
- No Condition, Healthy Individuals
- Keywords
- Ascilion AB, PELSA, dISF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ascilion ABIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PELSA Dermal Interstitial Fluid Sampling | Experimental | Device: PELSA SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-80 years of age (inclusive) at the time of ICF signature.
- Participant is willing to participate and is capable of giving informed consent.
- Participants must understand and sign the informed consent form, be able to comply with all study procedures and must be available for the duration of the study
Key exclusion criteria (7 listed)
- Known dermatologic condition at the site of measurement, including active skin injury, lesion, infection or other dermatologic condition
- Pregnant or breastfeeding persons
- The participant has recently taken NSAIDS (within 72 hours of screening), Aspirin (5 days), prescription anticoagulants (e.g. warfarin, 5 days), or P2Y12 antiplatelet therapies (1 week)
- Vulnerable persons
- On persons with an open wound in or near the sampling area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PELSA SystemAlso: PELSA, Hollow Microneedle Sampling SystemThe 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. | Device | PELSA Dermal Interstitial Fluid Sampling |
Primary outcome
Successful Collection of Dermal Interstitial Fluid
Time frame: During the sampling session
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus Magerl, MD, Ph.D. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PELSA System in people with No Condition, Healthy Individuals, run by Ascilion AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy P Bost, Ph.D. (+46728491672, jeremy.bost@ascilion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Collection of Dermal Interstitial Fluid (time frame: During the sampling session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.