Study of Dermal Interstitial Fluid Collection With a Vacuum-Assisted Microneedle Device

Part of paid clinical trials in Stanford, California.

Sponsor
Sharon Pitteri
Study ID
NCT07867028
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vacuum-Assisted Microneedle Device — DEVICE
    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 Details

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.

Key Dates

First listed
Oct 9, 2026
Start date
Oct 1, 2026
Status verified
Oct 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Vacuum-Assisted Microneedle Interstitial Fluid Collection
    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

Primary Outcome Measure

Volume of Dermal Interstitial Fluid Collected [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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By research site
Stanford University· Stanford, CA

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