[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658889":3},{"organization":4,"outcomesModule":7,"designInfo":70,"detailedDescription":81,"studyPopulation":75,"armGroups":82,"interventions":95,"overallOfficials":75,"centralContacts":75,"locations":75,"responsibleParty":106,"collaborators":108,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":75,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":149,"whyStopped":75,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":75},{"fullName":5,"class":6},"SpinaFX Medical Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Composite Clinical Success at 6 Months","Composite clinical success at 6 months requiring achievement of all of the following components:\n\n* Improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline\n* Freedom from reintervention or conversion to surgery at the index level\n* Freedom from device- or procedure-related serious adverse events (SAEs) or persistent new or worsening neurological deficit","6 Months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"ODI Responder Rate at 6 Months","Proportion of participants achieving an improvement of at least 15 points in Oswestry Disability Index (ODI) score compared with baseline.",{"measure":18,"description":19,"timeFrame":12},"Leg Pain Responder Rate at 6 Months","Proportion of participants achieving an improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline.",{"measure":21,"description":22,"timeFrame":23},"Incidence of Related Adverse Events and Serious Adverse Events","Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs).","Through 24 Months",[25,29,32,36,40,43,46,49,52,55,59,63,67],{"measure":26,"description":27,"timeFrame":28},"Pain Response at 12 Months","Proportion of participants achieving at least a 20 mm improvement in worse-leg VAS pain score compared with baseline.","12 Months",{"measure":30,"description":31,"timeFrame":28},"ODI Responder Rate at 12 Months","Proportion of participants achieving an improvement of at least 15 points in ODI score compared with baseline.",{"measure":33,"description":34,"timeFrame":35},"Patient Global Impression of Change (PGIC)","Participant-reported overall change following treatment.","1, 3, 6, and 12 Months",{"measure":37,"description":38,"timeFrame":39},"Change in ODI Score","Change from baseline in Oswestry Disability Index score.","6 and 12 Months",{"measure":41,"description":42,"timeFrame":39},"Change in Leg and Back Pain VAS Scores","Change from baseline in leg pain and back pain Visual Analog Scale scores.",{"measure":44,"description":45,"timeFrame":39},"Change in PROMIS-29 Score","Change from baseline in Health-Related Quality of Life (PROMIS-29) scores.",{"measure":47,"description":48,"timeFrame":39},"Change in Insomnia Severity Index (ISI) Score","Change from baseline in ISI score.",{"measure":50,"description":51,"timeFrame":39},"Change in Generalized Anxiety Disorder-7 (GAD-7) Score","Change from baseline in GAD-7 score.",{"measure":53,"description":54,"timeFrame":39},"Change in Patient Health Questionnaire-9 (PHQ-9) Score","Change from baseline in PHQ-9 score.",{"measure":56,"description":57,"timeFrame":58},"Change in Neurological Examination Findings","Change from baseline in motor, sensory, reflex, and straight-leg-raise neurological assessments.","6 and 12 months",{"measure":60,"description":61,"timeFrame":62},"MRI Assessment of Disc Morphology","MRI evaluation of disc herniation size, disc height, and disc degeneration using the modified Pfirrmann scale.","Base, 6 Months, and 12 Months",{"measure":64,"description":65,"timeFrame":66},"Time to Additional Intervention at the Treated Level","Time from index treatment to additional intervention at the treated level.","Through 12 Months",{"measure":68,"description":69,"timeFrame":66},"Healthcare Resource Utilization and Work Status","Cost analysis including subsequent treatments and work status.",{"allocation":71,"interventionModel":72,"interventionModelDescription":73,"primaryPurpose":74,"observationalModel":75,"timePerspective":75,"maskingInfo":76},"RANDOMIZED","PARALLEL","Participants who meet eligibility criteria will be randomized in a 1:1 ratio to one of two parallel treatment groups: (1) Triojection® System followed by Selective Nerve Root Block (SNRB), or (2) SNRB alone. Participants will remain in their assigned treatment group throughout the study and will be followed for 24 months after treatment. The study is participant-blinded, with investigators aware of treatment assignment.","TREATMENT",null,{"masking":77,"maskingDescription":78,"whoMasked":79},"SINGLE","This study is participant-blinded (single-blind). Participants will not be informed of their treatment assignment. Investigators and study personnel involved in performing the procedures will not be blinded because of the nature of the interventions. To help maintain blinding, procedure details and treatment-related imaging will not be reviewed with participants, and the Triojection® System console will be operated outside the participant's auditory range during treatment.",[80],"PARTICIPANT","Symptomatic lumbar disc herniation is a common cause of lumbar radiculopathy and may result in leg pain, with or without back pain, that can significantly affect daily activities and quality of life. Many patients improve with non-surgical treatment; however, some continue to experience symptoms despite conservative care and spinal injections and may ultimately consider surgical intervention.\n\nThis study is a prospective, randomized, participant-blinded, multi-center clinical trial designed to evaluate the safety and effectiveness of the Triojection® System for the treatment of symptomatic lumbar radiculopathy associated with a single-level contained herniated lumbar disc. The Triojection® System is an investigational device that generates and delivers a controlled ozone-oxygen gas mixture into the affected intervertebral disc under image guidance. The intended mechanism is reduction of disc volume through dehydration of disc material, which may reduce pressure on adjacent nerve structures and relieve symptoms.\n\nApproximately 300 participants will be randomized and treated at up to 30 investigational sites in the United States and Canada. Eligible participants will be adults 18 to 75 years of age with symptomatic lumbar radiculopathy resulting from a single-level contained lumbar disc herniation who have failed at least 6 weeks of non-surgical care and have previously undergone a lumbar spine injection with documented initial symptom improvement and subsequent recurrence of symptoms.\n\nParticipants will be randomized in a 1:1 ratio to one of two treatment groups:\n\n* Investigational treatment: Triojection® System followed by Selective Nerve Root Block (SNRB).\n* Control treatment: SNRB alone.\n\nParticipants will be followed for 24 months after treatment. Clinical evaluations will include patient-reported outcome measures, neurological and physical examinations, monitoring of adverse events, medication review, and assessment of additional treatments or surgical interventions. MRI evaluations will be performed at baseline and selected follow-up visits to assess radiographic changes in the treated disc.\n\nThe primary effectiveness evaluation will assess composite clinical success at 6 months after treatment, including improvement in leg pain and freedom from additional interventions or surgery at the treated level. The primary safety evaluation will assess freedom from device- or procedure-related serious adverse events and persistent new or worsening neurological deficits through 6 months. Secondary and exploratory assessments will evaluate disability, quality of life, pain outcomes, imaging findings, and long-term clinical outcomes through 24 months.\n\nThe results of this study are intended to provide evidence regarding the safety and effectiveness of the Triojection® System for treating symptomatic lumbar radiculopathy caused by a contained herniated lumbar disc.",[83,90],{"label":84,"type":85,"description":86,"interventionNames":87},"Investigational: Triojection® System + Selective Nerve Root Block (SNRB)","EXPERIMENTAL","Participants randomized to the investigational group will receive treatment with the Triojection® System, consisting of an intradiscal ozone-oxygen injection (35 ± 3 µg\u002FmL ozone in oxygen), followed by a Selective Nerve Root Block (SNRB) using dexamethasone and 0.25% bupivacaine (Marcaine).",[88,89],"Device: Triojection® System","Procedure: Selective Nerve Root Block (SNRB)",{"label":91,"type":92,"description":93,"interventionNames":94},"Active Comparator: Selective Nerve Root Block (SNRB) Alone","ACTIVE_COMPARATOR","Participants randomized to the control group will receive a Selective Nerve Root Block (SNRB) using dexamethasone and 0.25% bupivacaine (Marcaine) without treatment with the Triojection® System.",[89],[96,101],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":75},"DEVICE","Triojection® System","The Triojection® System is an investigational device that generates and delivers 12 mL of an ozone-oxygen gas mixture at a concentration of 35 ± 3 µg\u002FmL ozone in oxygen for image-guided intradiscal injection into a contained herniated lumbar disc.",[84],{"type":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":75},"PROCEDURE","Selective Nerve Root Block (SNRB)","Image-guided injection of dexamethasone and 0.25% bupivacaine (Marcaine) around the affected lumbar nerve root as standard of care treatment for lumbar radiculopathy.\n\nThese arm and intervention entries follow the standard ClinicalTrials.gov format for a randomized device study with an active comparator.",[91,84],{"type":107,"investigatorFullName":75,"investigatorTitle":75,"investigatorAffiliation":75,"oldNameTitle":75,"oldOrganization":75},"SPONSOR",[109],{"name":110,"class":6},"IQVIA Inc.","100658889","triojection-system-for-treating-lumbar-radiculopathy-caused-by-a-contained-herniated-lumbar-disc-100658889",false,"NCT07856810","Randomized Evaluation of Lumbar Injection Effectiveness and Function","Safety and Effectiveness of the Triojection® System in Patients With Symptomatic Lumbar Radiculopathy With or Without Back Pain Resultant From a Contained Herniated Lumbar Disc (L1-S1): A Pivotal, Randomized, Prospective, Multi-centered Study","RELIEF","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, participants must meet all of the following criteria:\n\n  1. Age between ≥18 (skeletally mature) - 75 (inclusive)\n  2. A single contained posterior lumbar disc herniation, at a single level L1-S1, no greater than 30% of the canal size confirmed by radiographic imaging (via MRI\u002FAxial MRI sequence)\n  3. Has a preoperative leg VAS ≥ 50 \u002F100 mm in worse leg AND worse leg is at least 20mm greater than the other leg\n  4. The target level herniated disc must have a disc height of at least 33% (1\u002F3) that of the adjacent disc levels, as determined by the investigator\n  5. The patient must have pain in a dermatomal distribution consistent with their radiographic findings.\n  6. Presents with leg pain for at least 6 weeks and that has not responded to conservative therapies (e.g., bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation \\[TENS\\], etc.).\n  7. Patient must have had a single previous epidural steroid injection or selective nerve root block at the target level with documentation of initial response and recurrence of symptoms (Prior injection must be at least 2 weeks or greater from screening visit)\n  8. Psychosocially, mentally and physically able to fully comply with the clinical protocol, provide informed consent, and willing to adhere to follow-up schedule and requirements\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from participating in this study:\n\n  1. Evidence of a symptomatic lumbar herniation at more than one level confirmed by patient history and radiographic imaging (via MRI)\n  2. Functional neurological deficit evident during neurological exam such as drop foot, incontinence, intractable pain, loss of bladder or bowel control, or rapidly worsening symptoms\n  3. Previous spine surgery in the lumbar region involving the index or adjacent level disc as evident on MRI, or instrumented hardware (e.g., total disc replacement, fusion) at any lumbar spine level\n  4. Earlier spinal procedures in the lumbar region involving the index or adjacent level discs (basal nerve ablation, radiofrequency ablation, MILD procedure)\n  5. Distal spinal cord compression on CT\u002FMRI\n  6. Evidence of cauda equina syndrome\n  7. Structural deformities i.e.,\n\n     1. ≥ Grade 2 spondylolisthesis (Up to Grade 1 allowed);\n     2. Severe Spinal canal stenosis;\n     3. Scoliosis \\> 10 degree Cobb Angle;\n     4. Loss of lumbar lordosis (i.e., flatback-syndrome diagnosis);\n     5. Hyperlordosis \\> 10 degrees;\n     6. Spinal fracture (at any level);\n     7. Disc extrusions or sequestered herniation as evident on CT\u002FMRI.\n  8. Evidence of a lumbar disc herniation with a maximal protrusion of disc material \\>4 mm beyond the posterior vertebral body margin, as assessed by screening MRI.\n  9. Calcified disc fragment as evident on CT\u002FMRI\n  10. Inaccessible index disc (e.g. due to, overlap of the iliac wings, and\u002For steep angulation of the L5\u002FS1 disc space.)\n  11. Participant has a bleeding disorder, medical condition, or is taking medications that would result in elevated risk (e.g., blood clotting) to undergoing the surgical procedure; or any other clinical reasons deemed by the Investigator in which the patient would not be an appropriate candidate for the study.\n  12. Any evidence of osteomyelitis\u002Fdiscitis at any level\n  13. Uncontrolled\u002Facute illness\n  14. Women who are pregnant or planning to become pregnant during follow-up time period.\n  15. Worker's compensation, injury litigation, disability remuneration.\n  16. Active participation in another clinical investigation or course of care that may confound the outcome of this study\n  17. Systemic infection or infection at the procedure site\n  18. Currently a prisoner\n  19. Leg pain of non-spinal or unknown etiology\n  20. Participant has a spinal cord stimulator\n  21. Diabetes with an HbA1c \\> 8.5\n  22. Severe peripheral neuropathy\n  23. Active foot ulcer\n  24. Any known allergy to steroids or SNRB anesthetic\n  25. Lumbar myelopathy\n  26. Active malignancy or planned chemotherapy during follow-up time period\n  27. Body Mass Index \\> 35\n  28. Evidence of chronic low back pain for ≥ 12 months that is non-responsive to conservative therapy\n  29. Current or recent history (within 90 days of screening) of chemical\u002Falcohol abuse or dependency using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code\n  30. Current or recent history (within 90 days of screening) of Severe anxiety using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code\n  31. Current or recent history (within 90 days of screening) of Major Depressive Disorder using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code\n  32. Any contraindication for MRI (e.g. claustrophobia)\n  33. Participant has had a previous lumbar discogram\n  34. Participant has modic changes at the treatment level (Type 3)\n  35. Participant has a Schmorl's node at the proposed treatment level\n  36. Participant has opioid medication usage \\> 20 MME (morphine milligram equivalent)\u002Fday or change in opioid prescription within 60 days of procedure\n  37. Participant is currently using a Fentanyl patch (at time of screening)\n  38. Participant has a known G6PD deficiency disorder","ALL","18 Years","75 Years",{"count":123,"type":124},300,"ESTIMATED","INTERVENTIONAL",[127],"NA","The goal of this clinical trial is to learn whether the Triojection® System is safe and effective for treating symptomatic lumbar radiculopathy (leg pain caused by nerve irritation or compression) resulting from a contained herniated lumbar disc. The study will enroll adults 18 to 75 years of age with a single-level contained lumbar disc herniation who continue to have symptoms despite at least 6 weeks of non-surgical treatment and a previous lumbar spine injection.\n\nThe main questions it aims to answer are:\n\n* Does treatment with the Triojection® System improve leg pain and overall clinical outcomes compared with Selective Nerve Root Block (SNRB) alone?\n* Is treatment with the Triojection® System safe, as measured by the absence of device- or procedure-related serious adverse events and persistent neurological deficits?\n\nResearchers will compare participants who receive Triojection® followed by SNRB with participants who receive SNRB alone to determine whether the investigational treatment provides improved clinical outcomes.\n\nParticipants will:\n\n* Be randomly assigned to receive either Triojection® plus SNRB or SNRB alone.\n* Complete questionnaires about leg pain, back pain, disability, quality of life, sleep, anxiety, depression, and overall improvement.\n* Undergo physical and neurological examinations during study follow-up visits.\n* Have MRI scans performed at selected study visits to evaluate changes in the treated disc.\n* Attend follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment.\n\nUp to 300 participants will be enrolled at up to 30 investigational sites in the United States and Canada and followed for approximately 24 months after treatment.",[130,131,132],"Lumbar Radiculopathy","Lumbar Disc Herniation","Contained Herniated Lumbar Disc",[98,134,135,136,137,130,138,139,140,141,142,143,144,145,146,147,148],"Triojection System","Triojection","Ozone-Oxygen Injection","Intradiscal Ozone Therapy","Herniated Lumbar Disc","Contained Disc Herniation","Selective Nerve Root Block","SNRB","Sciatica","Low Back Pain","Interventional Spine Procedure","Randomized Controlled Trial","Ozone Nucleolysis","Disc Decompression","SFX-001","NOT_YET_RECRUITING","2026-10-02",{"date":152,"type":153},"2026-10-07","ACTUAL",{"date":155,"type":124},"2027-01-15",{"date":157,"type":124},"2029-12-06",{"name":5,"class":6}]