Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 10:35 AM
Study NCT ID:
NCT05023135
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2021-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DeepView SnapShot Portable (DV-SSP): Device Training Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient', 'timeFrame': '3 weeks', 'description': "Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Burns', 'Wound Heal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects enrolled in this study will be recruited at the designated Study Site within 72 hours of suffering a thermal burn injury. Adult and pediatric Subjects with burns from one or more of the defined burn severities will be enrolled. All Subjects must meet the specified inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so;\n* Life expectancy \\> 6 months;\n* Thermal burn mechanism (flame, scald, or contact);\n* The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and\n* Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region\n* For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn.\n* For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn\n\nExclusion Criteria:\n\n* Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints;\n* Subject has burns involving \\> 50% total body surface area (TBSA);\n* Sepsis at the time of enrollment;\n* Immunosuppression/radiation/chemotherapy \\< 3 months prior to enrollment;\n* Concurrent use of investigational products with a known effect on the burn sites; and/or\n* Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.'}, 'identificationModule': {'nctId': 'NCT05023135', 'briefTitle': 'DeepView SnapShot Portable (DV-SSP): Device Training Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'SpectralMD'}, 'officialTitle': 'DeepView SnapShot Portable (DV-SSP): Device Training Study', 'orgStudyIdInfo': {'id': 'CT-2021-01--CSP-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with Thermal Burn Injury', 'description': 'An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury.', 'interventionNames': ['Device: DeepView SnapShot Portable (DV-SSP)']}], 'interventions': [{'name': 'DeepView SnapShot Portable (DV-SSP)', 'type': 'DEVICE', 'description': 'DV-SSP assistive imaging to collect observational data', 'armGroupLabels': ['Subjects with Thermal Burn Injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Valleywise Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Health Research Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'University Medical Center New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Medicine', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Christopher's Childrens Hospital", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SpectralMD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}