Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 3:29 PM
Study NCT ID:
NCT04782050
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2021-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005234', 'term': 'Fatty Liver'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of biomarkers to existing biomarker references', 'timeFrame': 'At study completion, 1 year', 'description': 'Biomarkers measurements performed with the device subject of the research and commercially available equipment (2 other devices used in routine care) will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.'}, {'measure': 'Diagnostic performance of biomarkers in research', 'timeFrame': 'At study completion, 1 year', 'description': 'Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to commercially available diagnostic biomarkers.\n\nConventional diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy.'}], 'secondaryOutcomes': [{'measure': 'Repeatability intraclass correlation coefficients (ICC)', 'timeFrame': 'At study completion, 1 year', 'description': 'Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator.'}, {'measure': 'Reproducibility intraclass correlation coefficients (ICC)', 'timeFrame': 'At study completion, 1 year', 'description': 'Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elastography', 'Attenuation', 'Sound speed', 'Ultrasound'], 'conditions': ['Liver Diseases', 'Liver Cirrhosis', 'Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).', 'detailedDescription': 'The study will enroll adult patients with known chronic liver disease, and referred to a hepatology outpatient visit for liver fibrosis assessment.\n\nPerformances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment.\n\nRepeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care).\n* Patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights\n* Patient who is registered to the French social security program\n\nExclusion Criteria:\n\n* Adult patients under guardianship\n* Adult patients not being under guardianship, unable to express consent for participation\n* Pregnant women\n* Breastfeeding women\n* Patients under deprivation of liberty\n* In-hospital patients not having given their consent to participate, or admitted in emergency\n* Patients admitted in social and care centers for other reasons than those of the research\n* Patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.'}, 'identificationModule': {'nctId': 'NCT04782050', 'acronym': 'DIACEPA', 'briefTitle': 'Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation', 'organization': {'class': 'INDUSTRY', 'fullName': 'E-Scopics'}, 'officialTitle': "Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie", 'orgStudyIdInfo': {'id': 'ES201'}, 'secondaryIdInfos': [{'id': '2021-A00612-39', 'type': 'OTHER', 'domain': 'ANSM (France - n°IDRCB)'}, {'id': '21.01563.000015', 'type': 'OTHER', 'domain': 'Ethical committee CPP Est I'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study arm', 'interventionNames': ['Device: Ultrasound liver assessment']}], 'interventions': [{'name': 'Ultrasound liver assessment', 'type': 'DEVICE', 'otherNames': ['Elastography', 'Ultrasound attenuation', 'Sound speed'], 'description': 'The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.', 'armGroupLabels': ['Study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'overallOfficials': [{'name': 'Victor de Lédinghen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'E-Scopics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}