An observational study in Lumbar Disc Herniation, sponsored by Beam Research, Inc.. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Beam Research, Inc. · Observational
This study is retrospectively designed and aims to evaluate and summarize safety and performance data in eligible participants who have undergone Intradiscal ozone-oxygen injection for treatment of lumbar disc herniation with the Triojection® System in Canada under Special Access Program (SAP) between April 2022 and 31 March 2026 at one(1) participating site.
The primary objectives of the study are :
Retrospective data will be collected from existing medical records across three predefined periods:
In addition, prospective data collection will be performed during a separate follow-up period of variable duration, consisting of follow-up visits conducted either remotely or in person to collect participant-reported outcomes including pain, function, work status, updated medical history, and medication use.
493 studies on the registry are indexed under Intervertebral Disc Displacement; 103 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 124 observational studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →This is the only study on the registry with Beam Research, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All consecutive participants treated with the Triojection system (including participants in which the procedure was attempted but not completed, if any) under SAP approval between April 2022 and 31 March 2026 on all-comer basis at one(1) participating site, without regard for their demographics, index condition or treated level(s).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For participation in the prospective phase, the subject must additionally meet the following criteria:
- Subject is willing and able to provide written informed consent for prospective data collection .
Exclusion Criteria:
As this study is intended to collect and report data on an all-comers basis representative of subjects encountered in routine clinical practice, no exclusion criteria have been defined.
Consecutive participants treated with the Triojection system (including participants in which the procedure was attempted but not completed, if any) under SAP approval between April 2022 and 31 March 2026 on all-comer basis at one(1) participating site, without regard for their demographics, index condition or treated level(s).
Device: Intradiscal ozone-oxygene injection
Intradiscal ozone-oxygen injection procedure with the Triojection® System for the treatment of lumbar disc herniation. Ozone/oxygen gas in a concentration of 35 ± 3 micrograms per milliliter (μg/ml) of ozone in oxygen directly in a sterile syringe.
Clinical success
Four-prong, Composite Clinical Success (CCS)
Time frame: Index procedure and up 180 days post-procedure [0, 180 d].
Incidence of Adverse Events (AEs).
Adverse events, including vital signs, clinical laboratory and/or other clinical measurements performed during the standard course of medical of care, will be assessed as per type, incidence, duration, severity, seriousness, and causal relationship to the device and study procedure.
Time frame: Through study completion, average of 3 months
Oswestry Disability Index (ODI)
Absolute and Mean Change from baseline in Oswestry Disability Index (ODI) and proportion of responders.
Time frame: Change in ODI will be evaluated at 6 weeks, 3 months, 6 months, 12 months, 24 months, and > 24 months.
Pain (Visual Analog Scale or Numeric Rating Scale)
Absolute and Mean change from baseline in Visual Analog (VAS) or Numeric Rating Scale (NRS) leg pain and proportion of responders. VAS (Visual Analog Scale): 10 cm (100 mm) horizontal line. Left = No pain. Right = Worst imaginable pain. Measured distance (cm or mm) from left end up to subject-reported point on the line. NPRS (Numeric Pain Rating Scale): 0 to 10. 0 = No pain. 10 = Worst imaginable pain.
Time frame: Change in pain will be evaluated at 6 weeks, 3 months, 6 months, 12 months, 24 months, and > 24 months.
Subsequent surgical interventions (SSIs)
Freedom from subsequent surgical interventions (SSIs) (any discectomy) at the index level(s)
Time frame: SSIs will be evaluated at 3 months, 6 months, 12 months, 24 months, and > 24 months.
Clinically significant non-surgical treatments
Freedom from clinically significant non-surgical treatments defined as intradiscal injections at an index level, or other injection use in the lumbar spine (i.e., trigger point or epidural steroid injection (ESI), and/or increase of opioid analgesics (Morphine milligram equivalent \[MME\])
Time frame: Clinically significant non-surgical treatments will be evaluated at 3 months, 6 months, 12 months, 24 months, and > 24 mon
Pain Inventory
Patient-Reported Pain Inventory using Numerical Pain Rating Scale (NPRS) and study-specific Questionnaire (7 questions). NPRS (Numeric Pain Rating Scale): 0 to 10. 0 = No pain. 10 = Worst imaginable pain.
Time frame: Through Study Completion, average of 3 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 8b
8-item patient-reported outcome tool evaluating physical function. Each item is scored on a 5-point Likert scale ranging from 1 ('Unable to do') to 5 ('Without any difficulty'). Raw scores are converted to a standardized T-score
Time frame: Through study completion, average of 3 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Intervertebral Disc Displacement →