Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-29 @ 6:56 AM
Study NCT ID:
NCT03996135
Status:
UNKNOWN
Last Update Posted:
2022-08-24
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Accuvein in Cirrhotics Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002404', 'term': 'Catheterization'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First Attempt Success Rate of Cannulation', 'timeFrame': 'baseline', 'description': 'Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.'}], 'secondaryOutcomes': [{'measure': 'change of the score A-DIVA', 'timeFrame': 'baseline and end of hospitalization (up to a month)', 'description': 'Scores A-DIVA between beginning and end of hospitalization between the two groups'}, {'measure': 'Cost', 'timeFrame': 'baseline', 'description': 'Cost of consumables used in euro between the two groups'}, {'measure': 'Life expectancy of the catheter', 'timeFrame': 'baseline', 'description': 'Life expectancy of the catheter between the two groups'}, {'measure': 'Utilisation of a central venous catheter', 'timeFrame': 'baseline', 'description': 'Use of a central venous catheter (y/n)'}, {'measure': "Pain's score", 'timeFrame': 'baseline', 'description': 'visual analogic scale'}, {'measure': 'Numbers of attempts', 'timeFrame': 'baseline', 'description': 'Number of attempts between two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18 years old\n* Patient presenting a liver cirrhosis\n* Patient requiring the placement of a venous peripheral catheter\n* Patient informed and giving free and informed consent\n* Patient affiliated to a French social security scheme\n\nExclusion Criteria:\n\n* Patient under 18 years old\n* Patient unable to give consent\n* Patient under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT03996135', 'acronym': 'CIRRVVUS', 'briefTitle': 'Evaluation of Accuvein in Cirrhotics Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients', 'orgStudyIdInfo': {'id': '19-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental : Cannulation with AccuVein AV400', 'description': 'Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation', 'interventionNames': ['Device: Cannulation with AccuVein AV400']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.'}], 'interventions': [{'name': 'Cannulation with AccuVein AV400', 'type': 'DEVICE', 'otherNames': ['AccuVein AV400'], 'description': 'Cannulation using AccuVein AV400 device', 'armGroupLabels': ['Experimental : Cannulation with AccuVein AV400']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Moiteaux', 'role': 'CONTACT', 'email': 'moiteaux-p@chu-caen.fr', 'phone': '+33231063106'}, {'name': 'Clémence Tomadesso', 'role': 'CONTACT', 'email': 'tomadesso-c@chu-caen.fr', 'phone': '+33231065386'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Philippe Moiteaux', 'role': 'CONTACT', 'email': 'moiteaux-p@chu-caen.fr', 'phone': '0231064542'}, {'name': 'Nelly Orliac', 'role': 'CONTACT', 'email': 'orliac-n@chu-caen.fr', 'phone': '0231063082'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}