Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT04993833
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inter-Device Reliability of the NPi-300 Pupillometer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Pupil's reaction to light as measured by Neurological Pupil Index (NPI)", 'timeFrame': '1 year', 'description': "Pupil's reaction to light as measured by Neurological Pupil Index (NPI) algorithm using pupillometer device that grades the pupil's reaction to light on a scale between 0 and 5. The Inter-device reliability is assessed using Cohen's Kappa method: values ≤ 0 as indicating no agreement."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Critical Illness', 'Neuropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.', 'detailedDescription': 'Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF.\n\nIf there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient Cohort: Patients admitted with a neurological or neurosurgical diagnosis that place them at risk for cerebral edema.\n\nHealthy Cohort: Faculty/Staff who interact with patients at the enrolling site', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Patient Cohort):\n\n* Subjects will be included if they are adults (\\>18 years of age) and have a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Subjects also have to be admitted to the enrolling site. Persons consenting for the study (whether patient or LAR) will need to be able to consent for the study in English.\n\nExclusion Criteria (Patient Cohort):\n\n* Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women.\n\nInclusion Criteria (Healthy Control Cohort):\n\n* Staff in the enrolling site\n\nExclusion Criteria (Healthy Control Cohort):\n\n* None'}, 'identificationModule': {'nctId': 'NCT04993833', 'acronym': 'TRIPLE', 'briefTitle': 'Inter-Device Reliability of the NPi-300 Pupillometer', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Inter-Device Reliability of the NPi-300 Pupillometer', 'orgStudyIdInfo': {'id': 'STU-2021-0693'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with risk of cerebral edema.', 'interventionNames': ['Device: NPi-200 and NPi-300 pupillometers']}, {'label': 'Healthy Control', 'description': 'Staff/Faculty who interact with patients at the enrolling site.', 'interventionNames': ['Device: NPi-200 and NPi-300 pupillometers']}], 'interventions': [{'name': 'NPi-200 and NPi-300 pupillometers', 'type': 'DEVICE', 'description': 'Device which measures PLR.', 'armGroupLabels': ['Healthy Control', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Clements University Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'DaiWai M Olson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeurOptics Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Neuroscience Nursing Research Center', 'investigatorFullName': 'DaiWai Olson', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}