Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:10 AM
Study NCT ID:
NCT07311733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-31
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Milky Way Sensor: Device Validation for Infiltrated Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-29', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Red Notification Sensitivity to Infiltrated Tissues', 'timeFrame': 'After each participant has been infiltrated, an expected average of 1 hour.', 'description': 'The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.'}], 'secondaryOutcomes': [{'measure': 'Yellow Notification Sensitivity to Infiltrated Tissues', 'timeFrame': 'After each participant has been infiltrated, an expected average of 1 hour.', 'description': 'The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.'}, {'measure': 'Significant Skin Irritation or Disruption to Skin Integrity', 'timeFrame': 'After each participant has been infiltrated, an expected average of 1 hour.', 'description': 'The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Infiltration of Peripheral IV Therapy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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 / 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®/warfarin, Eliquis®/apixaban).\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 / Aids\n* Immune deficiency disorder\n* Lymphedema\n* Major surgery or scar tissue which would complicate PIV access\n* Needle phobia\n* Radiation / 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'}, 'identificationModule': {'nctId': 'NCT07311733', 'briefTitle': 'Milky Way Sensor: Device Validation for Infiltrated Tissues', 'organization': {'class': 'INDUSTRY', 'fullName': 'ivWatch, LLC'}, 'officialTitle': 'Milky Way Sensor: Device Validation for Infiltrated Tissues', 'orgStudyIdInfo': {'id': 'IVW-CLR-CS38-400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infiltrated Tissue', 'description': '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/hr to 150 mL/hr.', 'interventionNames': ['Device: ivWatch Model 400 with Milky Way Sensor']}], 'interventions': [{'name': 'ivWatch Model 400 with Milky Way Sensor', 'type': 'DEVICE', 'description': 'The ivWatch Model 400 with Milky Way Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.', 'armGroupLabels': ['Infiltrated Tissue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'contacts': [{'name': 'Marisa Brown, BS', 'role': 'CONTACT', 'email': 'marisa.brown@ivwatch.com', 'phone': '(855) 489-2824'}], 'facility': 'ivWatch', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}], 'centralContacts': [{'name': 'Jason Naramore, MS', 'role': 'CONTACT', 'email': 'jason.naramore@ivwatch.com', 'phone': '(855) 489-2824'}, {'name': 'Marisa Brown, BS', 'role': 'CONTACT', 'email': 'marisa.brown@ivwatch.com', 'phone': '(855) 489-2824'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ivWatch, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}