Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT01843335
Status:
TERMINATED
Last Update Posted:
2017-10-31
First Post:
2013-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D057867', 'term': 'Endoleak'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'recruitment too slow', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-29', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of endoleak with CEUS', 'timeFrame': '9 months', 'description': 'Compare CEUS with computed tomography angiography (CTA) sensitivity for detection of endoleak'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular Diagnostic Technique', 'Ultrasound'], 'conditions': ['Abdominal Aortic Aneurysm', 'Endoleak']}, 'descriptionModule': {'briefSummary': 'X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in follow-up after endovascular implantation of abdominal aortic prothesis, Central Norway', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* in follow-up after endovascular implantation of abdominal aortic prothesis\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01843335', 'briefTitle': 'Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair', 'orgStudyIdInfo': {'id': '2013/359/REKnord'}}, 'contactsLocationsModule': {'locations': [{'zip': '7006', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Reidar Brekken, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan Normal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}, {'name': 'SINTEF Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}