HealthyMAPNCT07867028
Study of Dermal Interstitial Fluid Collection With a Vacuum-Assisted Microneedle Device
A study testing Vacuum-Assisted Microneedle Device in people with Healthy, run by Sharon Pitteri at 1 site in United States.
Trial summary
This study evaluates the collection of dermal interstitial fluid using a vacuum-assisted microneedle device in healthy adult volunteers. The study will assess the device-based collection procedure and characterize the collected dermal interstitial fluid. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vacuum-Assisted Microneedle Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Sep 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Willing to undergo microneedle array patch (MAP) application.
Who cannot join
- History of skin conditions that predispose the participant to adverse reactions to skin puncture. Examples include eczema, psoriasis, and keloids.
- Active infection, open wound, rash, or skin breakdown on the arm being used for MAP device application.
- Known allergy to acrylate or device materials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study evaluates the collection of dermal interstitial fluid using a vacuum-assisted microneedle device in healthy adult volunteers.
The study will assess the device-based collection procedure and characterize the collected dermal interstitial fluid.
Healthy adult volunteers will undergo dermal interstitial fluid collection using a vacuum-assisted microneedle device at the Stanford study site. Participants will complete the study procedures described in the protocol, which may include device application, vacuum-assisted microneedle sampling, collection and analysis of dermal interstitial fluid, assessment of procedure-related effects, and follow-up as specified by the study protocol.
- Conditions
- Healthy
- Being tested
- Vacuum-Assisted Microneedle Device
- Keywords
- dermal interstitial fluid, vacuum-assisted microneedle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-Assisted Microneedle DeviceDevice
The device comprises an adhesive alignment plate, an applicator containing a microneedle array patch, and a porous dome connected to a pre-evacuated collection tube. The patch is applied to the skin and immediately removed with the applicator. Vacuum then draws dermal interstitial fluid into the dome. Collection typically lasts 5 minutes, with a maximum of 30 minutes per attempt and an expected yield of approximately 15 microliters. Up to two additional collections at different skin sites are permitted with participant permission if the yield is insufficient. Configurations may use different-size collection tubes; flat domes or domes with different curvature radii; and aligned-perforation or triply periodic minimal surface lattice geometries. Each participant receives one configuration.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum-Assisted Microneedle Interstitial Fluid Collection | Experimental | Healthy adult volunteers aged 18 years or older will undergo dermal interstitial fluid collection using a vacuum-assisted microneedle device during a single study visit. Each participant will receive one device configuration selected according to the current stage of device development. Collection typically lasts 5 minutes and will not exceed 30 minutes per attempt. With participant permission, collection may be repeated up to twice at different skin sites if the amount collected is insufficient. Participants will receive instructions to report delayed device-related adverse events occurring within 30 days Receives: Device: Vacuum-Assisted Microneedle Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Dermal Interstitial Fluid Collected
Volume of dermal interstitial fluid obtained using the vacuum-assisted microneedle device, measured in microliters. Collection performance will be evaluated for the device configuration used during each participant's study visit.
Measured: Baseline
Secondary outcomes (1)
Participant-Reported Pain Associated With Device Use,Reported Ability to Operate the Device With Minimal Assistance and safety
Each participant will receive a survey asking them to rate the pain associated with ISF collection. Some participants will be asked to operate the device with minimal assistance. Study personnel will observe task completion and note difficulties. Safety events will be identified through the investigator's observation during the procedure and participant reports of delayed events.
Measured: Baseline and up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single-site study will enroll 50 healthy adult volunteers to evaluate a vacuum-assisted microneedle device for dermal interstitial fluid collection. Each participant will undergo collection using one device configuration during a single study visit. Configurations will be evaluated sequentially as engineering refinements are developed; configuration assignment will depend on the current stage of development and will not be randomized. With participant permission, collection may be repeated up to twice at different skin sites if the amount collected is insufficient. Participants will receive instructions to report delayed device-related adverse events occurring within 30 days.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharon Pitteri
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor-investigator, Sharon Pitteri, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867028
- Sponsor's protocol ID
- 84762
- Acronym
- MAP
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Dermal Interstitial Fluid Collection With a Vacuum-Assisted Microneedle Device
- ClinicalTrials.gov ID
- NCT07867028
- Acronym / sponsor ID
- MAP / 84762
- Conditions
- Healthy
- Keywords
- dermal interstitial fluid, vacuum-assisted microneedle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sharon PitteriUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 9 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 study evaluates the collection of dermal interstitial fluid using a vacuum-assisted microneedle device in healthy adult volunteers.
The study will assess the device-based collection procedure and characterize the collected dermal interstitial fluid.
Healthy adult volunteers will undergo dermal interstitial fluid collection using a vacuum-assisted microneedle device at the Stanford study site. Participants will complete the study procedures described in the protocol, which may include device application, vacuum-assisted microneedle sampling, collection and analysis of dermal interstitial fluid, assessment of procedure-related effects, and follow-up as specified by the study protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-site study will enroll 50 healthy adult volunteers to evaluate a vacuum-assisted microneedle device for dermal interstitial fluid collection. Each participant will undergo collection using one device configuration during a single study visit. Configurations will be evaluated sequentially as engineering refinements are developed; configuration assignment will depend on the current stage of development and will not be randomized. With participant permission, collection may be repeated up to twice at different skin sites if the amount collected is insufficient. Participants will receive instructions to report delayed device-related adverse events occurring within 30 days.
| Arm | Type | Receives |
|---|---|---|
| Vacuum-Assisted Microneedle Interstitial Fluid Collection | Experimental | Device: Vacuum-Assisted Microneedle DeviceHealthy adult volunteers aged 18 years or older will undergo dermal interstitial fluid collection using a vacuum-assisted microneedle device during a single study visit. Each participant will receive one device configuration selected according to the current stage of device development. Collection typically lasts 5 minutes and will not exceed 30 minutes per attempt. With participant permission, collection may be repeated up to twice at different skin sites if the amount collected is insufficient. Participants will receive instructions to report delayed device-related adverse events occurring within 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older.
- Willing to undergo microneedle array patch (MAP) application.
Key exclusion criteria (3 listed)
- History of skin conditions that predispose the participant to adverse reactions to skin puncture. Examples include eczema, psoriasis, and keloids.
- Active infection, open wound, rash, or skin breakdown on the arm being used for MAP device application.
- Known allergy to acrylate or device materials.
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 |
|---|---|---|
| Vacuum-Assisted Microneedle DeviceThe device comprises an adhesive alignment plate, an applicator containing a microneedle array patch, and a porous dome connected to a pre-evacuated collection tube. The patch is applied to the skin and immediately removed with the applicator. Vacuum then draws dermal interstitial fluid into the dome. Collection typically lasts 5 minutes, with a maximum of 30 minutes per attempt and an expected yield of approximately 15 microliters. Up to two additional collections at different skin sites are permitted with participant permission if the yield is insufficient. Configurations may use different-size collection tubes; flat domes or domes with different curvature radii; and aligned-perforation or triply periodic minimal surface lattice geometries. Each participant receives one configuration. | Device | Vacuum-Assisted Microneedle Interstitial Fluid Collection |
Primary outcome
Volume of Dermal Interstitial Fluid Collected
Time frame: Baseline
Volume of dermal interstitial fluid obtained using the vacuum-assisted microneedle device, measured in microliters. Collection performance will be evaluated for the device configuration used during each participant's study visit.
1 secondary outcome
Participant-Reported Pain Associated With Device Use,Reported Ability to Operate the Device With Minimal Assistance and safety
Time frame: Baseline and up to 30 days.
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-Assisted Microneedle Device in people with Healthy, run by Sharon Pitteri at 1 site in United States.
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 2 inclusion and 3 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 9 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Dermal Interstitial Fluid Collected (time frame: Baseline). 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 9 Oct 2026.