Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT03658018
Status:
WITHDRAWN
Last Update Posted:
2019-08-15
First Post:
2018-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No Enrollments', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-07-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-08-31', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '3 months', 'description': 'Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'Mean change in Visual Analog Scale (VAS) pain score from baseline to 3, 6, 9 and 12 months post-treatment. Scale is measured from 0 to 10, better to worse respectively.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '6, 9, and 12 months', 'description': 'Mean change in Oswestry Disability Index (ODI) score from baseline to 6, 9 and 12 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting', 'detailedDescription': 'This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Skeletally mature subjects age 25-70 years, inclusive\n* Chronic lower back pain for at least six months\n* Failure to respond to at least six months of non-operative conservative management\n* Oswestry Disability Index (ODI) at time of evaluation of at least 30 points\n* Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1\n\nExclusion Criteria:\n\n* Radicular pain by history or evidence of pain neurological deficit within the past one year.\n* Previous surgery performed on the lumbar spine\n* Current or history of symptomatic spinal stenosis\n* Current or history of osteoporotic or tumor-related vertebral body compression fracture\n* Current or history of vertebral cancer or spinal metastasis\n* Current or history of spinal infection\n* Metabolic bone disease\n* BMI greater or equal to 40\n* Any radiographic evidence of other important back pathology\n* MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1\n* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain\n* Subjects who are bed bound\n* Demonstrates 3 or more Waddell's signs of Inorganic Behavior\n* Any evidence of current systemic infection"}, 'identificationModule': {'nctId': 'NCT03658018', 'acronym': 'CLBP', 'briefTitle': 'Intraosseous Basivertebral Nerve Ablation for Treatment of Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Relievant Medsystems, Inc.'}, 'officialTitle': 'A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'CIP 0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracept System Ablation', 'interventionNames': ['Device: Intracept System Ablation']}], 'interventions': [{'name': 'Intracept System Ablation', 'type': 'DEVICE', 'description': 'Radiofrequency ablation using Intracept System', 'armGroupLabels': ['Intracept System Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Back Institute', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Isador Lieberman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Back Institute'}]}, 'ipdSharingStatementModule': {'url': 'http://clbpstudy.com', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'At the completion of trial', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Relievant Medsystems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}