Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-23 @ 3:49 PM
Study NCT ID:
NCT01593358
Status:
UNKNOWN
Last Update Posted:
2012-05-08
First Post:
2012-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Venous Obstruction in Neurodegenerative Disorders Research Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-05', 'studyFirstSubmitDate': '2012-05-05', 'studyFirstSubmitQcDate': '2012-05-05', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CCSVI'], 'conditions': ['Chronic Cerebral Spinal Venous Insufficiency']}, 'descriptionModule': {'briefSummary': 'To establish if there are venous obstructions in patients with neurodegenerative disorders', 'detailedDescription': 'This research registry will observe the venous obstruction in neurodegenerative disorders. This will provide data that will allow researchers to classify abnormal valve and venous morphology, distinguish vessels which are more responsive to treatment, determine groups who respond more favorably to treatment, and overall evaluate the outcomes of venous angioplasty in various neurodegenerative disorders that involve venous obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Human subjects will be approached for participation in this registry that are receiving or seeking medical care at Synergy Health Concepts, Inc.No individuals shall be excluded from participation in the Research Registry based on race, ethnicity, or gender.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent\n* Males or Females between the ages of 18 and 90 years of age\n* Voluntary agreement to participate in the Venous Obstructions in Neurodegenerative Diseases Research Registry\n\nExclusion Criteria:\n\n* Any implantable/metallic objects that prevent subject from having a magnetic resonance imaging ( MRI/MRV) study\n* History of uncontrolled hypertension\n* Previous venous angioplasty treatment for Chronic cerebral spinal venous insufficiency\n* Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women,fetuses, and cognitively impaired individuals who are unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01593358', 'briefTitle': 'Venous Obstruction in Neurodegenerative Disorders Research Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synergy Health Concepts, Inc.'}, 'officialTitle': 'Venous Obstruction in Neurodegenerative Disorders Research Registry', 'orgStudyIdInfo': {'id': 'RESEARCH_REGISTRY'}}, 'contactsLocationsModule': {'locations': [{'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frances Debarge-Igoe, RN', 'role': 'CONTACT', 'phone': '949-221-0129'}, {'name': 'John Joseph Hewett, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Synergy Health Concepts, Inc.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'centralContacts': [{'name': 'Frances DeBarge-Igoe, RN', 'role': 'CONTACT', 'email': 'uscangionurse@aol.com', 'phone': '(949) 221-0129'}], 'overallOfficials': [{'name': 'John Joseph Hewett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synergy Health Concepts, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}