Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-04 @ 8:30 AM
Study NCT ID:
NCT04129034
Status:
UNKNOWN
Last Update Posted:
2022-12-01
First Post:
2019-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-03', 'releaseDate': '2025-05-19'}], 'estimatedResultsFirstSubmitDate': '2025-05-19'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, non-randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-03-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS', 'timeFrame': 'Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure', 'description': 'Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain'}, {'measure': 'Procedure and Device Safety at six months as measured by measured by the incidence and severity of treatment related adverse events', 'timeFrame': 'Time Frame: 6 months after procedure', 'description': 'Safety will be measured by the incidence and severity of treatment related adverse events'}], 'secondaryOutcomes': [{'measure': 'Lesion Size', 'timeFrame': '2 days post procedure', 'description': 'Lesion size and location as shown in MRI Image, 2 days post treatment.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure', 'description': 'Low Back Pain Questionnaire (Range: 0% to 100%)'}, {'measure': 'Short Form 12 (SF-12)', 'timeFrame': 'Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure', 'description': 'A multipurpose short form survey with 12 questions (Range: 0 to 100)'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure', 'description': 'Patient Global Impression of Change (Range: 1 to 7)'}, {'measure': 'Procedure and Device Safety as measured by measured by the incidence and severity of treatment related adverse events', 'timeFrame': 'Time Frame: Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure', 'description': 'Safety will be measured by the incidence and severity of treatment related adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic low back pain', 'zygapophyseal joint syndrome', 'Facet syndrome'], 'conditions': ['Facet Syndrome of Lumbar Spine']}, 'referencesModule': {'references': [{'pmid': '38580339', 'type': 'DERIVED', 'citation': 'Gofeld M, Smith KJ, Bhatia A, Djuric V, Leblang S, Rebhun N, Aginsky R, Miller E, Skoglind B, Hananel A. Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study. Reg Anesth Pain Med. 2025 Jun 10;50(6):464-470. doi: 10.1136/rapm-2024-105345.'}]}, 'descriptionModule': {'briefSummary': 'Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain', 'detailedDescription': 'Study design: Prospective, single arm\n\nTimeline: six month enrollment period and 6 months follow-up period.\n\nSites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport \\& Spine, Kinetix Integrated Orthopaedic \\& Regenerative Medicine\n\nStudy population: Thirty adult patients diagnosed with facet related low back pain.\n\nPrimary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome.\n\nSafety is measured by the incidence and severity of treatment related adverse events.\n\nEfficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult male and females \\>55 years of age legally able and willing to participate in the study and come for follow-up visits\n2. Able and willing to fill the research questionnaires and to communicate with investigator and research team\n3. Patient with bilateral or unilateral low back pain of \\> 6 months duration\n4. Patients whose back pain is alleviated by recumbency or comfortable sitting position\n5. Patients presenting with a) a positive (\\>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (\\>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.\n6. Average pain score of 6 or higher in the last month, (on 0-10 scale).\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding patient\n2. Patients younger than 55 or older than 85 years\n3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).\n4. Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy\n5. Patients who have had lumbar radiofrequency neurotomy in the past 6 months\n6. Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine\n7. Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI)\n8. Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location.\n9. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome per PI decision.\n10. Patient with extensive scarring of the skin and tissue overlying the treatment area.\n11. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project\n12. Any patients with an uncontrolled coagulopathy\n13. Patients with known osteoporosis with absolute risk of spinal fracture of \\>10% over 10 years will be excluded\n14. Any patients with a history of malignant disease in the past five years\n15. Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.\n16. Patients known for concomitant psychiatric disorders, excluding mood disorders.\n17. Patients presenting with concomitant mood disorders (deemed severe by the research physician).\n18. Patients with a first-degree family member already enrolled in this study.\n19. Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date\n20. Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)"}, 'identificationModule': {'nctId': 'NCT04129034', 'briefTitle': 'Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'FUSMobile Inc.'}, 'officialTitle': 'Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'LBP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound', 'interventionNames': ['Device: Neurolyser XR']}], 'interventions': [{'name': 'Neurolyser XR', 'type': 'DEVICE', 'description': 'Non-Invasive Thermal Ablation of the Medial Branch Nerves', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BC V6K 2E4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Kinetix Medicine', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L6L 1H5', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Precision Sport & Spine', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'M3H 5S4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Silver Medical Group', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Alan Edwards Pain Management Unit - Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FUSMobile Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-05-19', 'type': 'RELEASE'}, {'date': '2025-06-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'FUSMobile Inc.'}}}}