Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-10 @ 12:24 AM
Study NCT ID:
NCT07009405
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thermal skin measurements', 'timeFrame': 'Up to 12 hours of monitoring with a 15-minute follow-up period.', 'description': 'Exploratory assessment of thermal skin measurements taken with the study device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['IV Infiltration', 'IV Extravasation']}, 'descriptionModule': {'briefSummary': 'This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Scheduled to receive an infusion therapy of at least 30 minutes in length\n2. Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device\n3. Signed informed consent\n4. Available for 15 minutes of post-measurement monitoring following removal of the study device\n\nExclusion Criteria:\n\n1. Patient is under 12 years of age\n2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm\n3. Use of the study device would interfere with standard patient care that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject\n4. Investigator judges that the intravenous'}, 'identificationModule': {'nctId': 'NCT07009405', 'briefTitle': 'Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhaeos, Inc.'}, 'officialTitle': 'Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures', 'orgStudyIdInfo': {'id': '2025-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Infusion Patients', 'description': 'Pediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study.', 'interventionNames': ['Device: non-invasive thermal infusion site monitoring NTISM device']}], 'interventions': [{'name': 'non-invasive thermal infusion site monitoring NTISM device', 'type': 'DEVICE', 'description': 'Non-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements', 'armGroupLabels': ['IV Infusion Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Dube', 'role': 'CONTACT', 'phone': '8473246800'}, {'name': 'Matthew Dube', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Infusacare', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}], 'centralContacts': [{'name': 'Anna Somera', 'role': 'CONTACT', 'email': 'clinical@rhaeos.com', 'phone': '855-814-3569'}], 'overallOfficials': [{'name': 'R. Chad Webb', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhaeos, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhaeos, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}