[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659723":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":26,"interventions":33,"overallOfficials":18,"centralContacts":18,"locations":39,"responsibleParty":52,"collaborators":56,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":79,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline and up to 30 days.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"NA","SINGLE_GROUP","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.","DIAGNOSTIC",{"masking":25,"maskingDescription":18,"whoMasked":18},"NONE",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"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",[32],"Device: Vacuum-Assisted Microneedle Device",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":18},"DEVICE","Vacuum-Assisted Microneedle 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.",[28],[40],{"facility":5,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":18},"Stanford","California","94305","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-122.16608,37.42411,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Sharon Pitteri","Professor (Research) of Radiology (Diagnostic Sciences Laboratory)",[57],{"name":5,"class":6},"100659723","study-of-dermal-interstitial-fluid-collection-with-a-vacuum-assisted-microneedle-device-100659723",false,"NCT07867028","Study of Dermal Interstitial Fluid Collection With a Vacuum-Assisted Microneedle Device","MAP","Inclusion Criteria:\n\n* 18 years of age or older.\n* Willing to undergo microneedle array patch (MAP) application.\n\nExclusion Criteria:\n\n* History of skin conditions that predispose the participant to adverse reactions to skin puncture. Examples include eczema, psoriasis, and keloids.\n* Active infection, open wound, rash, or skin breakdown on the arm being used for MAP device application.\n* Known allergy to acrylate or device materials.",true,"ALL","18 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[20],"This study evaluates the collection of dermal interstitial fluid using a vacuum-assisted microneedle device in healthy adult volunteers.\n\nThe study will assess the device-based collection procedure and characterize the collected dermal interstitial fluid.\n\nHealthy 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.",[75],"Healthy",[77,78],"dermal interstitial fluid","vacuum-assisted microneedle","NOT_YET_RECRUITING","2026-10-06",{"date":82,"type":83},"2026-10-09","ACTUAL",{"date":85,"type":70},"2026-10-01",{"date":87,"type":70},"2030-09-01",{"name":54,"class":6},1]