Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01605851
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2012-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GORE® Septal Occluder European Union Clinical Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2012-05-18', 'studyFirstSubmitQcDate': '2012-05-24', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO', 'timeFrame': '6 months', 'description': 'The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure'}], 'secondaryOutcomes': [{'measure': 'Additional Clinical Success evaluated during the procedure and 6 months post-procedure', 'timeFrame': '6 months', 'description': 'Technical Success, Procedure Success, Closure Success'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PFO', 'closure'], 'conditions': ['Closure; Foramen Ovale']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Subjects with a PFO less than or equal to 17mm'}, 'identificationModule': {'nctId': 'NCT01605851', 'briefTitle': 'GORE® Septal Occluder European Union Clinical Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'GORE® Septal Occluder EU Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of Patent Foramen Ovale (PFO)', 'orgStudyIdInfo': {'id': 'GSO 11-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Closure, Foramen Ovale', 'description': 'Patients undergoing device closure of PFO', 'interventionNames': ['Device: Closure, Foramen Ovale']}], 'interventions': [{'name': 'Closure, Foramen Ovale', 'type': 'DEVICE', 'armGroupLabels': ['Closure, Foramen Ovale']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Medical Center of Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Heidelberg University Hospital', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'German Heart Center', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'San Donato', 'country': 'Italy', 'facility': 'Hospital Group of San Donato', 'geoPoint': {'lat': 45.08201, 'lon': 7.66485}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}