Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-31 @ 12:45 PM
Study NCT ID:
NCT05155800
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2021-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare ICH in TBI patients to non-ICH control subjects', 'timeFrame': 'up to 12 months', 'description': '1\\. Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.'}, {'measure': 'Measure growth of intracranial hemorrhage', 'timeFrame': 'up to 12 months', 'description': '2\\. Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The study population will consist of 3 mutually-exclusive sets of patients and subjects:\n\n* TBI patients with intracranial bleeding\n* TBI patients without intracranial bleeding\n* Control subjects with normal brain health.\n\nResearch subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of 3 mutually-exclusive sets of patients and subjects:\n\n* TBI patients with intracranial bleeding\n* TBI patients without intracranial bleeding\n* Control subjects with normal brain health.\n\nResearch subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:\n\n * Male or female subjects age 22 to 50\n * Patients with TBI who have a diagnostic head CT scan within 24 hours of the injury.\n * For patients with TBI without intracranial hemorrhage, Glasgow Coma Scale score at enrollment of ≤ 14.\n * For patients with TBI, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment.\n * Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian.\n * Willingness and ability to comply with schedule for study procedures.\n * Control subjects with normal brain health.\n\nExclusion Criteria:\n\n* All subjects meeting any of the following criteria will be excluded from this study:\n\n * Female patients who are pregnant or lactating.\n * Known history of seizure or clinical seizure prior to initiating SENSE monitoring.\n * Open skull fracture.\n * Metallic intracranial clip, coil, or device (such as metallic ICP monitor).\n * Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study.\n * Planned placement of an intraventricular catheter after the diagnostic (pre-enrollment) CT.\n * Planned withdrawal of care within 24 hours of enrollment.\n * Planned intracranial surgery within 24 hours of enrollment.\n * Current participation in a medical or surgical interventional clinical trial.\n * Planned or current use of continuous EEG monitoring.\n * Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI"}, 'identificationModule': {'nctId': 'NCT05155800', 'acronym': 'Sense-005', 'briefTitle': 'A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sense Diagnostics, LLC'}, 'officialTitle': "A Prospective, Non-Randomized, Sequentially Enrolled, Multi-Center, Phase II Study to Evaluate the SENSE Device's Ability to Detect and Monitor Traumatic Brain Injury", 'orgStudyIdInfo': {'id': 'Sense-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TBI patients with intracranial bleeding', 'interventionNames': ['Device: SDx3']}, {'label': 'TBI patients without intracranial bleeding', 'interventionNames': ['Device: SDx3']}, {'label': 'Control Subjects with normal brain health', 'interventionNames': ['Device: SDx3']}], 'interventions': [{'name': 'SDx3', 'type': 'DEVICE', 'description': 'The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.', 'armGroupLabels': ['Control Subjects with normal brain health', 'TBI patients with intracranial bleeding', 'TBI patients without intracranial bleeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'UC Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Jonathan Ratcliff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sense Diagnostics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}