[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616908":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":20,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":20,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"ivWatch, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infiltrated Tissue","EXPERIMENTAL","The ivWatch Milky Way sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL\u002Fhr to 150 mL\u002Fhr.",[13],"Device: ivWatch Model 400 with Milky Way Sensor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ivWatch Model 400 with Milky Way Sensor","The ivWatch Model 400 with Milky Way Sensor monitored the site during the course of the infiltration and issued red and\u002For yellow notifications if an infiltration was detected.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jason Naramore, MS","CONTACT","(855) 489-2824","jason.naramore@ivwatch.com",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Marisa Brown, BS","marisa.brown@ivwatch.com",[31],{"facility":32,"status":20,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"ivWatch","Newport News","Virginia","23606","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-76.42975,36.98038,{"lat":42,"lon":41},[45],{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100616908","milky-way-sensor-device-validation-for-infiltrated-tissues-100616908",false,"NCT07311733","Milky Way Sensor: Device Validation for Infiltrated Tissues","Inclusion Criteria:\n\n* 18 years of age or older\n* Healthy, verified by an eligible designation on the Health History Form\n\nExclusion Criteria:\n\n* Abnormal bleeding \u002F hemophilia\n* Absence of sensation in one or both arms\n* Allergy to common medical materials\n* Blood clotting disorder\n* Currently enrolled in another clinical trial\n* Current hepatitis infection or any history of hepatitis B or C\n* Currently pregnant\n* Daily regimen of blood thinning medication (e.g., aspirin, ibuprofen, naproxen, Coumadin®\u002Fwarfarin, Eliquis®\u002Fapixaban).\n* Fever at the time of study visit (≥100.4°F)\n* Frequent dizziness or fainting spells, especially with needles\n* History of chronic, severe anemia\n* History of stroke\n* HIV \u002F Aids\n* Immune deficiency disorder\n* Lymphedema\n* Major surgery or scar tissue which would complicate PIV access\n* Needle phobia\n* Radiation \u002F chemotherapy in the last year\n* Received IV therapy in 14 days prior to study visit\n* Severe dehydration on day of study visit\n* Sick or had an infection in 14 days prior to study visit\n* Tattoo(s) that severely limits vein visualization at a sensor monitoring location\n* Unstable or uncontrolled cardiopulmonary disorder\n* Uncontrolled seizures",true,"ALL","18 Years",{"count":58,"type":59},28,"ESTIMATED","INTERVENTIONAL",[62],"NA","A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.",[65],"Infiltration of Peripheral IV Therapy","NOT_YET_RECRUITING","2025-12-29",{"date":69,"type":70},"2025-12-31","ACTUAL",{"date":72,"type":59},"2026-01",{"date":74,"type":59},"2026-02",{"name":5,"class":6},1]