Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT01796535
Status:
UNKNOWN
Last Update Posted:
2013-03-15
First Post:
2012-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The PerX360º System™ Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-13', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2013-02-19', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fusion', 'timeFrame': '1 year', 'description': 'Image Assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['DDD']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.', 'detailedDescription': 'For all patients participating in the registry, the following outcomes will be analyzed:\n\n* Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain\n* Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain\n* Change in Oswestry Disability Index (ODI) score from baseline\n* Proportion of patients with a device related complication\n* Proportion of patients with lack of revision, removal, or reoperation\n* Proportion of patients with radiographic fusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects treated with the Optiport™ and Opticage™ products', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient understands the nature of the procedure and provides written informed consent\n* Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment\n* Age \\> 18 years\n* Patient is treated with the Optiport™ and Opticage™ products\n\nExclusion Criteria:None'}, 'identificationModule': {'nctId': 'NCT01796535', 'acronym': 'OptiLIF™', 'briefTitle': 'The PerX360º System™ Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Interventional Spine, Inc.'}, 'officialTitle': 'An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™', 'orgStudyIdInfo': {'id': 'TP201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PerX360º System™', 'description': 'Patients treated with PerX360º System™'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Rappard', 'role': 'CONTACT', 'email': 'rappardnancy@gmail.com', 'phone': '323-857-5300', 'phoneExt': '202'}, {'name': 'Dr. Rappard', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Los Angeles Brain and Spine Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32086', 'city': 'Saint Augustine', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Greenwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Flagler Hospital', 'geoPoint': {'lat': 29.89469, 'lon': -81.31452}}], 'centralContacts': [{'name': 'Michelle Butler', 'role': 'CONTACT', 'email': 'mbutler@i-spineinc.com', 'phone': '858 220 6904'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Interventional Spine, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}