Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-01-06 @ 8:49 AM
Study NCT ID:
NCT00233350
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2005-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2005-10-04', 'studyFirstSubmitQcDate': '2005-10-04', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neuronavigation', 'Ultrasound', 'Brain tumour surgery', 'Biopsy', 'Histopathology', 'Intraoperative imaging', '3D ultrasound imaging'], 'conditions': ['Brain Neoplasms']}, 'referencesModule': {'references': [{'pmid': '20652608', 'type': 'RESULT', 'citation': 'Solheim O, Selbekk T, Jakola AS, Unsgard G. Ultrasound-guided operations in unselected high-grade gliomas--overall results, impact of image quality and patient selection. Acta Neurochir (Wien). 2010 Nov;152(11):1873-86. doi: 10.1007/s00701-010-0731-5. Epub 2010 Jul 21.'}]}, 'descriptionModule': {'briefSummary': '3D ultrasound is a new modality used in image guided neurosurgery. a multicentre study is started for the evaluation of this tool as a means for achieving total resection of brain tumors at greater safety.', 'detailedDescription': 'The degree of resection as judged by the surgeon is recorded at the end of surgery for each patient, and then compared with the postoperative MRI. Neurological status before and after surgery, QOL before surgery and at follow-up as well as survival is recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who were operated for intracranial high-grade gliomas (World Health Organisation(WHO) grade III/IV) in the 3-year period between January 1st 2007 and December 31st 2009 in the Department of Neurosurgery, St. Olavs University Hospital, Trondheim, Norway', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Supratentorial glioma\n\nExclusion Criteria:\n\n* Not willing to participate in study'}, 'identificationModule': {'nctId': 'NCT00233350', 'briefTitle': 'Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Clinical Evaluation of Navigated 3D Ultrasound Multicentre Study', 'orgStudyIdInfo': {'id': 'Multicentre_3DUS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'use of navigated 3D ultrasound during surgery', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Geirmund Unsgaard, MD, 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'}], 'responsibleParty': {'type': 'SPONSOR'}}}}