Sharon Pitteri
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.
Inclusion Criteria: * 18 years of age or older. * Willing to undergo microneedle array patch (MAP) application. Exclusion Criteria: * 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.
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.
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