Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 7:47 PM
Study NCT ID:
NCT04415294
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flicker App for Minimal Hepatic Encephalopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CFF Agreement', 'timeFrame': '1 day', 'description': 'Level of agreement between Flicker App CFF and gold-standard device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy']}, 'descriptionModule': {'briefSummary': 'There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients', 'detailedDescription': 'SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in clinic supervised by a research assistant and calculate the level of agreement between the CFF determined by the Flicker-App, the CFF determined by the "gold-standard" FFS device, and the test scores on the EncephalApp Stroop test.\n\nSA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these CFF measurements.\n\nSA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical Gastroenterologists/Hepatologists'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cirrhosis patients without Grade III or IV OHE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis (standard criteria)\n* Chronic liver disease\n\nExclusion Criteria:\n\n* Grade III or IV hepatic encephalopathy\n* Mini-mental state examination score ≤25 (suggestive of dementia)\n* alcohol or illicit drug use within 3 months\n* current use of benzodiazepines\n* antiepileptics or psychotropic drugs\n* color blindness\n* severe vision impairment (blindness, macular degeneration).'}, 'identificationModule': {'nctId': 'NCT04415294', 'briefTitle': 'Flicker App for Minimal Hepatic Encephalopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Evaluating a Novel, Self-administered Device ("Flicker-App") That Measures Critical Flicker Frequency as a Test for Minimal Hepatic Encephalopathy in Cirrhosis', 'orgStudyIdInfo': {'id': 'STUDY00004521'}, 'secondaryIdInfos': [{'id': 'R21DK117431', 'link': 'https://reporter.nih.gov/quickSearch/R21DK117431', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Critical flicker frequency', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Yacoub', 'role': 'CONTACT', 'email': 'yacoum@medicine.washington.edu', 'phone': '206-744-3402'}], 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Michael Yacoub', 'role': 'CONTACT', 'email': 'yacoum@washington.medicine.edu', 'phone': '2067443402'}], 'overallOfficials': [{'name': 'George N Ioannou, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, School of Medicine', 'investigatorFullName': 'George Ioannou', 'investigatorAffiliation': 'University of Washington'}}}}