Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
Study NCT ID:
NCT04218292
Status:
UNKNOWN
Last Update Posted:
2021-04-23
First Post:
2020-01-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-05-11', 'releaseDate': '2022-02-23'}], 'estimatedResultsFirstSubmitDate': '2022-02-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2020-01-02', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of serious device-related and procedure-related adverse events', 'timeFrame': '12 months', 'description': 'Rate of serious device-related and procedure-related adverse events'}], 'secondaryOutcomes': [{'measure': 'Rate of successful delivery of the device', 'timeFrame': '1 day', 'description': 'Rate of successful delivery of the Micro Plug device to the intended position.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Trauma Injury', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring routine standard of care for peripheral embolization. Some of the patients will be liver cancer patients undergoing palliative treatment with SIRT who have a life expectancy that may be less than 12 months. Other patients may be treated for trauma or bleeding.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is scheduled for arterial embolization in the peripheral vasculature.\n* Subject is greater than 18 years of age\n\nExclusion Criteria:\n\n* Subject is unable to give informed consent\n* Subject is pregnant or breastfeeding\n* Subject has allergy to nickel\n* Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.'}, 'identificationModule': {'nctId': 'NCT04218292', 'briefTitle': 'Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan', 'organization': {'class': 'INDUSTRY', 'fullName': 'KA Medical, LLC'}, 'officialTitle': 'Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan', 'orgStudyIdInfo': {'id': 'PMCF 24October2019'}, 'secondaryIdInfos': [{'id': 'KAM-P4-21-01', 'type': 'OTHER', 'domain': 'Merit Medical Systems, Inc.'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Micro Plug Set', 'type': 'DEVICE', 'description': 'The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'University Hospital Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}], 'overallOfficials': [{'name': 'Maciej Pech, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Magdeburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KA Medical, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merit Medical Systems, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-02-23', 'type': 'RELEASE'}, {'date': '2022-05-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'KA Medical, LLC'}}}}