Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT02507102
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System', 'timeFrame': '6 months'}, {'measure': 'Tumor Response', 'timeFrame': '2 months', 'description': 'Tumor imaging response (RANO) at two months of therapy.'}], 'secondaryOutcomes': [{'measure': 'Overall survival at six months compared with historical response', 'timeFrame': '6 months'}, {'measure': 'Progression free survival', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': 'This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has histologically confirmed diagnosis of GBM.\n2. Subject has failed or intolerant to radiotherapy.\n3. Subjects has failed or intolerant to temozolomide therapy.\n4. Subject has progressive disease with at least one measureable lesion on MRI or CT.\n5. Subject is at least 18 years of age.\n6. Subject has a KPS ≥ 60.\n7. Subject has adequate organ and marrow function.\n8. Subject has provided signed informed consent.\n\nExclusion Criteria:\n\n1. Subject has life expectancy less than eight weeks\n2. Subject has received other investigational therapy within the last 28 days.\n3. Subject has received surgery within the last two weeks or not fully from prior surgery.\n4. Subject has a clinically significant electrolyte abnormality.\n5. Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device.\n6. Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.\n7. Subject is known to be HIV positive.\n8. Subject is pregnant, nursing or intends to become pregnant during the study period.\n9. Subject is participating in other investigational research.\n10. Subject has any condition that at the discretion of the investigator would preclude participation in the study.\n11. Subject is unable or unwilling to comply with the protocol-required follow-up schedule.'}, 'identificationModule': {'nctId': 'NCT02507102', 'briefTitle': 'A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nativis, Inc.'}, 'officialTitle': 'A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia', 'orgStudyIdInfo': {'id': 'NAT-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Voyager Therapy', 'description': 'Investigational treatment with Voyager Therapy', 'interventionNames': ['Device: Voyager']}], 'interventions': [{'name': 'Voyager', 'type': 'DEVICE', 'description': 'Non-invasive RFE therapy', 'armGroupLabels': ['Investigational Voyager Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3065', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "St. Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Donna Morgan Murray, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nativis, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nativis, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}