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

NCT07867028 | Not Yet Recruiting FDA Device

• 1 other identifier: 84762
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

dermal interstitial fluid; vacuum-assisted microneedle

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Participant-Reported Pain Associated With Device Use,Reported Ability to Operate the Device With Minimal Assistance and safety

  Baseline and up to 30 days.

Study Arms (1)

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

Device: Vacuum-Assisted Microneedle Device

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.

Vacuum-Assisted Microneedle Interstitial Fluid Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Willing to undergo microneedle array patch (MAP) application.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharon Pitteri: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor (Research) of Radiology (Diagnostic Sciences Laboratory)

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)