Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT04449835
Status:
TERMINATED
Last Update Posted:
2023-01-05
First Post:
2020-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Intracept Global Registry ( TIGR ) - Pilot Study
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Pilot Study converted to NCT 05660512 prospective single arm cohort study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI) Reduction', 'timeFrame': '3 months post procedure', 'description': 'Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). Comparison of mean ODI baseline to 3 months.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI) improvement', 'timeFrame': '3, 12, 24, 36, 48 and 60 months post procedure', 'description': 'Mean improvement in ODI scores from baseline (scale 0 to 100)'}, {'measure': 'Numeric Pain Score', 'timeFrame': '3, 12, 24, 36, 48 and 60 months post procedure', 'description': 'Mean reduction in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable)'}, {'measure': 'Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2)', 'timeFrame': '3, 12, 24, 36, 48 and 60 months post procedure', 'description': 'Percent of responders meeting both thresholds'}, {'measure': 'PROMIS 29 Change', 'timeFrame': '3, 12, 24, 36, 48 and 60 months post procedure', 'description': 'Mean change in PROMIS-29 from baseline'}, {'measure': 'Injections utilization compared to baseline', 'timeFrame': '3, 12, 24, 36, 48 and 60 months post procedure', 'description': 'Numbers of injections post procedure compared to baseline'}, {'measure': 'Post ablation pain interventions/surgeries', 'timeFrame': '3, 12, 24, 36, 48 and 60 months post procedure', 'description': 'Numbers of pain interventions/surgeries post procedure compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.\n\nRegistry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.', 'detailedDescription': 'Participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure.\n\nPrimary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that have the Intracept procedure and whose treating physician is referring to the registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients scheduled for the Intracept procedure and whose treating physician is referring to the registry\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04449835', 'briefTitle': 'The Intracept Global Registry ( TIGR ) - Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Relievant Medsystems, Inc.'}, 'officialTitle': 'The Intracept Global Registry', 'orgStudyIdInfo': {'id': 'CIP 0014'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intracept Procedure', 'type': 'PROCEDURE', 'description': 'radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Zachary McCormick, MD, FAAPMR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spine and Pain Medicine, University of Utah School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Relievant Medsystems, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'M Squared Associates, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor and Director of Clinical Spine Research', 'investigatorFullName': 'Zack McCormick', 'investigatorAffiliation': 'University of Utah'}}}}