Lumbar Disc HerniationNCT07910422
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
An observational study of Lumbar Disc Herniation, run by Beam Research, Inc. at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Intradiscal ozone-oxygene injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 17 Aug 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- Participant is greater than or equal to 18 years of age;
- Participant has consented to and has undergone (attempted or completed) an intradiscal ozone-oxygen injection procedure with the Triojection® System for the treatment of lumbar disc herniation in Canada under an approved SAP request at the participating site between April 2022 and 31 March 2026;
- Participant is willing and able to provide written informed consent for retrospective data collection.
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Performance of Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation - A Retrospective-Prospective Real-World Study.
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 :
Read more
- To evaluate the clinical success in eligible participants who have undergone intradiscal ozone-oxygen injection procedure with the Triojection® System for treatment of lumbar disc herniation.
- To evaluate the safety in eligible participants who have undergone the procedure.
Retrospective data will be collected from existing medical records across three predefined periods:
- Baseline, defined as within 180 days prior to treatment (index procedure);
- Treatment, of variable duration, encompassing clinic admission, performance of the index procedure, post-procedure recovery, and discharge;
- Follow-up, of variable duration, including any follow-up visits performed after discharge as part of the standard course of medical care.
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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Intradiscal ozone-oxygene injection
- Keywords
- intradiscal ozone injection, lumbar disc herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradiscal ozone-oxygene injectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intradiscal ozone-oxygen injection Cohort | 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). Receives: Device: Intradiscal ozone-oxygene injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Four-prong, Composite Clinical Success (CCS)
Measured: 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.
Measured: Through study completion, average of 3 months
Secondary outcomes (4)
Oswestry Disability Index (ODI)
Absolute and Mean Change from baseline in Oswestry Disability Index (ODI) and proportion of responders.
Measured: 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.
Measured: 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)
Measured: 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])
Measured: Clinically significant non-surgical treatments will be evaluated at 3 months, 6 months, 12 months, 24 months, and > 24 mon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start17 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beam Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- ViaClinica
- Responsible party
- Principal investigator, Olivier Clerk-Lamalice, Beam Research, Inc.
- Investigators
- Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP, Principal investigator, Beam Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910422
- Sponsor's protocol ID
- SPFX-2026-01
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation - A Retrospective-Prospective Real-World Study.
- ClinicalTrials.gov ID
- NCT07910422
- Acronym / sponsor ID
- SPFX-2026-01
- Conditions
- Lumbar Disc Herniation
- Keywords
- intradiscal ozone injection, lumbar disc herniation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beam Research, Inc.University, hospital or other
- Collaborators
- ViaClinica
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- To evaluate the clinical success in eligible participants who have undergone intradiscal ozone-oxygen injection procedure with the Triojection® System for treatment of lumbar disc herniation.
- To evaluate the safety in eligible participants who have undergone the procedure.
Retrospective data will be collected from existing medical records across three predefined periods:
- Baseline, defined as within 180 days prior to treatment (index procedure);
- Treatment, of variable duration, encompassing clinic admission, performance of the index procedure, post-procedure recovery, and discharge;
- Follow-up, of variable duration, including any follow-up visits performed after discharge as part of the standard course of medical care.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intradiscal ozone-oxygen injection Cohort | – | Device: Intradiscal ozone-oxygene injectionConsecutive 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (5 listed)
- Participant is greater than or equal to 18 years of age;
- Participant has consented to and has undergone (attempted or completed) an intradiscal ozone-oxygen injection procedure with the Triojection® System for the treatment of lumbar disc herniation in Canada under an approved SAP request at the participating site between April 2022 and 31 March 2026;
- Participant is willing and able to provide written informed consent for retrospective data collection.
- 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 .
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradiscal ozone-oxygene injectionIntradiscal 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. | Device | Intradiscal ozone-oxygen injection Cohort |
Primary outcome
Clinical success
Time frame: Index procedure and up 180 days post-procedure [0, 180 d].
Four-prong, Composite Clinical Success (CCS)
Incidence of Adverse Events (AEs).
Time frame: Through study completion, average of 3 months
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.
4 secondary outcomes
Oswestry Disability Index (ODI)
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)
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)
Time frame: SSIs will be evaluated at 3 months, 6 months, 12 months, 24 months, and > 24 months.
Clinically significant non-surgical treatments
Time frame: Clinically significant non-surgical treatments will be evaluated at 3 months, 6 months, 12 months, 24 months, and > 24 mon
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP principal investigator
Beam Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation, run by Beam Research, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: Index procedure and up 180 days post-procedure [0, 180 d].). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.