Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-31 @ 6:28 AM
Study NCT ID:
NCT04927156
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002538', 'term': 'Intracranial Arteriovenous Malformations'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020785', 'term': 'Central Nervous System Vascular Malformations'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2041-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2041-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of occurrence of device-specific safety indicator(s).', 'timeFrame': 'From the procedure to 12 months post-procedure depending on the device family.', 'description': 'Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.'}, {'measure': 'Rate of devices achieving its intended use.', 'timeFrame': 'From the procedure to 12 months post-procedure depending on the device family.', 'description': 'Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.'}, {'measure': 'Rate of devices achieving its specific performance indicator(s).', 'timeFrame': 'From the procedure to 12 months post-procedure depending on the device family.', 'description': 'Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.'}, {'measure': 'Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator', 'timeFrame': 'From the procedure to 12 months post-procedure depending on the device family.', 'description': 'Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['catheter', 'guidewire'], 'conditions': ['Intracranial Aneurysm', 'Brain Arterial Disease', 'Acute Ischemic Stroke', 'Peripheral Vascular Diseases', 'AVM - Cerebral Arteriovenous Malformation', 'AVM', 'Fistulas Arteriovenous']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.health-data-hub.fr/projets/securite-performance-et-utilisabilite-des-dispositifs-medicaux-balt-plateforme-de-suivi', 'label': 'HDH'}]}, 'descriptionModule': {'briefSummary': 'BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.\n\nThis platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include the BALT medical devices under consideration used in their respective indications for use during interventions performed at the participating sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of a signed, written and dated informed consent or non-opposition (where applicable)\n\nExclusion Criteria\n\n* Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)\n* Contra-indications of each device as described in the instructions for use.'}, 'identificationModule': {'nctId': 'NCT04927156', 'acronym': 'EVIDENCE', 'briefTitle': 'Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform', 'organization': {'class': 'INDUSTRY', 'fullName': 'Balt Extrusion'}, 'officialTitle': 'Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection', 'orgStudyIdInfo': {'id': 'CIP-202002-BALT DEVICES'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BALT medical devices', 'interventionNames': ['Device: BALT medical devices']}], 'interventions': [{'name': 'BALT medical devices', 'type': 'DEVICE', 'description': 'Includes, but is not limited to, the following:\n\n* Access devices\n* Aneurysm treatment devices\n* Ischemic Stroke and peripheral occlusive diseases treatment devices\n* Arterio-Venous Malformations/fistulas treatment devices', 'armGroupLabels': ['BALT medical devices']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne PASCO PAPON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tristan KERDRAON', 'role': 'CONTACT', 'email': 'tristan.kerdraon@chu-bordeaux.fr'}, {'name': 'Gaultier MARNAT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Kamel Boubagra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Bricout, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Estrade', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien DUCASSE', 'role': 'CONTACT', 'email': 'julien.ducasse@aphp.fr'}, {'name': 'Laurent Spelle', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kremlin Bicêtre - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '37000', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Bibi', 'role': 'CONTACT'}, {'name': 'Dr Bibi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chu Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'zhanna Svatko', 'role': 'CONTACT', 'email': 'zhanna.svatko@uk-halle.de'}, {'name': 'Stefan Schob', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '28222', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eduardo Crespo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Claudio Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital: Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'TERMINATED', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '33011', 'city': 'Oviedo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro Vega, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unversitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Andrés Gonzalez Mandly', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Enrique Montes', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Marqués de Valdecilla (HUMV)', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Zaragoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rosario Barrena, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Clinical Affairs Department', 'role': 'CONTACT', 'email': 'Evidence@baltgroup.com', 'phone': '+33 1 39 89 46 41'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balt Extrusion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}