Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-02 @ 3:38 AM
Study NCT ID:
NCT03247166
Status:
UNKNOWN
Last Update Posted:
2017-08-11
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety', 'timeFrame': '24 months', 'description': 'Subjects with no serious device complications as defined in the radiological protocol'}], 'primaryOutcomes': [{'measure': 'Pain Improvement', 'timeFrame': '24 months', 'description': 'Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score'}, {'measure': 'Function Improvement', 'timeFrame': '24 months', 'description': 'Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score'}, {'measure': 'Fusion Prevention', 'timeFrame': '24 months', 'description': 'The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Back Pain']}, 'descriptionModule': {'briefSummary': 'The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis\n* Patients with degenerative spondylolisthesis\n* Patients with at least 3 months failed conservative treatment\n* Narrowing of the lumbar spinal canal\n* Patients with lower back pain or sciatica\n\nExclusion Criteria:\n\n* Discogenic back pain at TOPS System level\n* Back or non-radicular leg pain of unknown etiology at TOPS System level\n* Lytic spondylolisthesis at TOPS System level\n* More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure\n* Known allergy to titanium and/or polyurethane'}, 'identificationModule': {'nctId': 'NCT03247166', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System', 'orgStudyIdInfo': {'id': 'HYMC-36-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lower Back and Leg Pain Patients', 'description': 'Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System', 'interventionNames': ['Device: TOPS™ System']}], 'interventions': [{'name': 'TOPS™ System', 'type': 'DEVICE', 'description': 'The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints', 'armGroupLabels': ['Lower Back and Leg Pain Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Ilana Alony, RN', 'role': 'CONTACT', 'email': 'ilanaa@hy.health.gov.il', 'phone': '972-4-6304487'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Ilana Alony, RN', 'role': 'CONTACT', 'email': 'ilanaa@hy.health.gov.il', 'phone': '972-4-6304487'}], 'overallOfficials': [{'name': 'Eyal Behrbalk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}