Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-05 @ 8:23 AM
Study NCT ID:
NCT06544135
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ABI', 'timeFrame': 'Up to 90 days before revascularization; Up to 1 year after revascularization', 'description': 'Ankle brachial index will be taken before and after intervention and correlated with thermal readings from FLIR.'}], 'secondaryOutcomes': [{'measure': 'Major amputations', 'timeFrame': 'Up to 1 year after revascularization', 'description': 'Any associated amputations the subject had after revascularization'}, {'measure': 'Major revascularizations post-initial intervention', 'timeFrame': 'Up to 1 year after revascularization', 'description': 'Any revascularization procedures done after the initial revascularization'}, {'measure': 'Mortality', 'timeFrame': 'Up to 1 year after revascularization', 'description': 'Subject deaths during the length of the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease', 'Critical Limb Ischemia', 'Critical Lower Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.\n\nThe main question this study aims to answer is:\n\n\\- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?', 'detailedDescription': 'This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.\n\nPatients with lower extremity PAD will be seen in office pre-intervention. Consent to participate in the TIC study will be acquired at this point. Patients will be given a physical copy of their consent form at the time consent is obtained. During this initial visit or subsequent pre-procedural office visit, the smartphone-based thermal camera will be utilized to measure the temperature of the lower extremity foot, ankle, and leg at the plantar, dorsal, and lateral distributions. Comorbidities and demographic factors will be documented from medical records at this time as well.\n\nData will be gathered at a consistent location to minimize impact of room temperature on measurements.\n\nPatients will then undergo scheduled revascularization with the interventionist.\n\nPost-intervention pictures will be taken immediately after revascularization.\n\nPatients will then be seen again by the research team for follow-up thermal camera imaging, 1 week post-intervention, and weekly post intervention for at least 1 month but up to 6 months.\n\nThermal measurements will be correlated with intra-op imaging and clinical outcomes in data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People between ages 18 and 99 years with lower extremity peripheral artery disease with a planned endovascular intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.\n* Planned lower extremity endovascular intervention\n\nExclusion Criteria:\n\n* Non-arterial ulcers\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT06544135', 'acronym': 'TIC', 'briefTitle': 'Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention', 'orgStudyIdInfo': {'id': 'STUDY20230726'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FLIR thermal imaging group', 'description': 'Temperature measurements will be taken of the lower limb using the FLIR camera and correlated with other aspects of each patient.', 'interventionNames': ['Device: FLIR One Pro LT']}], 'interventions': [{'name': 'FLIR One Pro LT', 'type': 'DEVICE', 'description': 'Thermal imaging camera used to measure temperatures of the lower limb.', 'armGroupLabels': ['FLIR thermal imaging group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Li, MD', 'role': 'CONTACT'}, {'name': 'Tarek Hammad, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospitals Ahuja Medical Center', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Li, MD', 'role': 'CONTACT', 'email': 'Jun.Li@UHhospitals.org', 'phone': '440-882-0075'}, {'name': 'Mehdi H Shishehbor, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tarek Hammad, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44129', 'city': 'Parma', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jun Li, MD', 'role': 'CONTACT'}, {'name': 'Yulanka Castro, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospitals Parma Medical Center', 'geoPoint': {'lat': 41.40477, 'lon': -81.72291}}], 'centralContacts': [{'name': 'Jun Li, MD', 'role': 'CONTACT', 'email': 'jun.li@uhhospitals.org', 'phone': '(734) 968-5212'}, {'name': 'Grace Craig, DPM', 'role': 'CONTACT', 'email': 'gracecraigdpm@gmail.com', 'phone': '408 628 8102'}], 'overallOfficials': [{'name': 'Jun Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}