Lumbar RadiculopathyRELIEFNCT07856810
Randomized Evaluation of Lumbar Injection Effectiveness and Function
A study testing Triojection® System and Selective Nerve Root Block (SNRB) in people with Lumbar Radiculopathy and Lumbar Disc Herniation, run by SpinaFX Medical Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Radiculopathy, Lumbar Disc Herniation, Contained Herniated Lumbar Disc
- What is being tested?
- Triojection® System and Selective Nerve Root Block (SNRB)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 6 Dec 2029
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, participants must meet all of the following criteria:
- Age between ≥18 (skeletally mature) - 75 (inclusive)
- 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/Axial MRI sequence)
- Has a preoperative leg VAS ≥ 50 /100 mm in worse leg AND worse leg is at least 20mm greater than the other leg
- The target level herniated disc must have a disc height of at least 33% (1/3) that of the adjacent disc levels, as determined by the investigator
- The patient must have pain in a dermatomal distribution consistent with their radiographic findings.
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- 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.).
- 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)
- 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
Who cannot join
- Participants who meet any of the following criteria will be excluded from participating in this study:
- Evidence of a symptomatic lumbar herniation at more than one level confirmed by patient history and radiographic imaging (via MRI)
- Functional neurological deficit evident during neurological exam such as drop foot, incontinence, intractable pain, loss of bladder or bowel control, or rapidly worsening symptoms
- 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
- Earlier spinal procedures in the lumbar region involving the index or adjacent level discs (basal nerve ablation, radiofrequency ablation, MILD procedure)
- Distal spinal cord compression on CT/MRI
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- Evidence of cauda equina syndrome
- Structural deformities i.e.,
- ≥ Grade 2 spondylolisthesis (Up to Grade 1 allowed);
- Severe Spinal canal stenosis;
- Scoliosis > 10 degree Cobb Angle;
- Loss of lumbar lordosis (i.e., flatback-syndrome diagnosis);
- Hyperlordosis > 10 degrees;
- Spinal fracture (at any level);
- Disc extrusions or sequestered herniation as evident on CT/MRI.
- 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.
- Calcified disc fragment as evident on CT/MRI
- Inaccessible index disc (e.g. due to, overlap of the iliac wings, and/or steep angulation of the L5/S1 disc space.)
- 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.
- Any evidence of osteomyelitis/discitis at any level
- Uncontrolled/acute illness
- Women who are pregnant or planning to become pregnant during follow-up time period.
- Worker's compensation, injury litigation, disability remuneration.
- Active participation in another clinical investigation or course of care that may confound the outcome of this study
- Systemic infection or infection at the procedure site
- Currently a prisoner
- Leg pain of non-spinal or unknown etiology
- Participant has a spinal cord stimulator
- Diabetes with an HbA1c > 8.5
- Severe peripheral neuropathy
- Active foot ulcer
- Any known allergy to steroids or SNRB anesthetic
- Lumbar myelopathy
- Active malignancy or planned chemotherapy during follow-up time period
- Body Mass Index > 35
- Evidence of chronic low back pain for ≥ 12 months that is non-responsive to conservative therapy
- Current or recent history (within 90 days of screening) of chemical/alcohol abuse or dependency using standard medical definition of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) code
- 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
- 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
- Any contraindication for MRI (e.g. claustrophobia)
- Participant has had a previous lumbar discogram
- Participant has modic changes at the treatment level (Type 3)
- Participant has a Schmorl's node at the proposed treatment level
- Participant has opioid medication usage > 20 MME (morphine milligram equivalent)/day or change in opioid prescription within 60 days of procedure
- Participant is currently using a Fentanyl patch (at time of screening)
- Participant has a known G6PD deficiency disorder
About this study
Official title: 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
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.
The main questions it aims to answer are:
Read more
- Does treatment with the Triojection® System improve leg pain and overall clinical outcomes compared with Selective Nerve Root Block (SNRB) alone?
- Is treatment with the Triojection® System safe, as measured by the absence of device- or procedure-related serious adverse events and persistent neurological deficits?
Researchers 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.
Participants will:
- Be randomly assigned to receive either Triojection® plus SNRB or SNRB alone.
- Complete questionnaires about leg pain, back pain, disability, quality of life, sleep, anxiety, depression, and overall improvement.
- Undergo physical and neurological examinations during study follow-up visits.
- Have MRI scans performed at selected study visits to evaluate changes in the treated disc.
- Attend follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment.
Up 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.
Read the detailed description
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.
This 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.
Approximately 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.
Participants will be randomized in a 1:1 ratio to one of two treatment groups:
- Investigational treatment: Triojection® System followed by Selective Nerve Root Block (SNRB).
- Control treatment: SNRB alone.
Participants 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.
The 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.
The 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.
- Being tested
- Triojection® System, Selective Nerve Root Block (SNRB)
- Keywords
- Triojection® System, Triojection System, Triojection, Ozone-Oxygen Injection, Intradiscal Ozone Therapy, Lumbar Radiculopathy, 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
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement, Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triojection® SystemDevice
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/mL ozone in oxygen for image-guided intradiscal injection into a contained herniated lumbar disc.
Selective Nerve Root Block (SNRB)Procedure or surgery
Image-guided injection of dexamethasone and 0.25% bupivacaine (Marcaine) around the affected lumbar nerve root as standard of care treatment for lumbar radiculopathy.
These arm and intervention entries follow the standard ClinicalTrials.gov format for a randomized device study with an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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/mL ozone in oxygen), followed by a Selective Nerve Root Block (SNRB) using dexamethasone and 0.25% bupivacaine (Marcaine). Receives: Device: Triojection® System; Procedure: Selective Nerve Root Block (SNRB) |
| 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. Receives: Procedure: Selective Nerve Root Block (SNRB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Success at 6 Months
Composite clinical success at 6 months requiring achievement of all of the following components:
- Improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline
- Freedom from reintervention or conversion to surgery at the index level
- Freedom from device- or procedure-related serious adverse events (SAEs) or persistent new or worsening neurological deficit
Measured: 6 Months
Secondary outcomes (3)
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.
Measured: 6 Months
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.
Measured: 6 Months
Incidence of Related Adverse Events and Serious Adverse Events
Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs).
Measured: Through 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion14 Jun 2028 (estimated)
- Study completion6 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpinaFX Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856810
- Sponsor's protocol ID
- SFX-001
- Acronym
- RELIEF
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At the time of study registration, the sponsor has not yet determined whether de-identified individual participant data (IPD) will be made available to other researchers. Any future decisions regarding data sharing will consider participant privacy, informed consent provisions, applicable regulatory requirements, and sponsor policies. If a data-sharing plan is established, the ClinicalTrials.gov record will be updated accordingly.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07856810
- Acronym / sponsor ID
- RELIEF / SFX-001
- Keywords
- Triojection® System, Triojection System, Triojection, Ozone-Oxygen Injection, Intradiscal Ozone Therapy, Lumbar Radiculopathy, Herniated Lumbar Disc, Contained Disc Herniation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- SpinaFX Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Inc.
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 14 Jun 2028 (estimated)
- Study completion
- 6 Dec 2029 (estimated)
- First posted
- 5 Oct 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.
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.
The main questions it aims to answer are:
- Does treatment with the Triojection® System improve leg pain and overall clinical outcomes compared with Selective Nerve Root Block (SNRB) alone?
- Is treatment with the Triojection® System safe, as measured by the absence of device- or procedure-related serious adverse events and persistent neurological deficits?
Researchers 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.
Participants will:
- Be randomly assigned to receive either Triojection® plus SNRB or SNRB alone.
- Complete questionnaires about leg pain, back pain, disability, quality of life, sleep, anxiety, depression, and overall improvement.
- Undergo physical and neurological examinations during study follow-up visits.
- Have MRI scans performed at selected study visits to evaluate changes in the treated disc.
- Attend follow-up visits at 1, 3, 6, 12, 18, and 24 months after treatment.
Up 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.
Detailed description
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.
This 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.
Approximately 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.
Participants will be randomized in a 1:1 ratio to one of two treatment groups:
- Investigational treatment: Triojection® System followed by Selective Nerve Root Block (SNRB).
- Control treatment: SNRB alone.
Participants 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.
The 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.
The 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Investigational: Triojection® System + Selective Nerve Root Block (SNRB) | Experimental | Device: Triojection® System, Procedure: Selective Nerve Root Block (SNRB)Participants randomized to the investigational group will receive treatment with the Triojection® System, consisting of an intradiscal ozone-oxygen injection (35 ± 3 µg/mL ozone in oxygen), followed by a Selective Nerve Root Block (SNRB) using dexamethasone and 0.25% bupivacaine (Marcaine). |
| Active Comparator: Selective Nerve Root Block (SNRB) Alone | Active comparator | Procedure: Selective Nerve Root Block (SNRB)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, participants must meet all of the following criteria:
Key exclusion criteria (46 listed)
- Participants who meet any of the following criteria will be excluded from participating in this study:
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 |
|---|---|---|
| Triojection® SystemThe 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/mL ozone in oxygen for image-guided intradiscal injection into a contained herniated lumbar disc. | Device | Investigational: Triojection® System + Selective Nerve Root Block (SNRB) |
| 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. These arm and intervention entries follow the standard ClinicalTrials.gov format for a randomized device study with an active comparator. | Procedure or surgery | Active Comparator: Selective Nerve Root Block (SNRB) Alone, Investigational: Triojection® System + Selective Nerve Root Block (SNRB) |
Primary outcome
Composite Clinical Success at 6 Months
Time frame: 6 Months
Composite clinical success at 6 months requiring achievement of all of the following components: * Improvement of at least 20 mm in worse-leg Visual Analog Scale (VAS) pain score compared with baseline * Freedom from reintervention or conversion to surgery at the index level * Freedom from device- or procedure-related serious adverse events (SAEs) or persistent new or worsening neurological deficit
3 secondary outcomes
ODI Responder Rate at 6 Months
Time frame: 6 Months
Leg Pain Responder Rate at 6 Months
Time frame: 6 Months
Incidence of Related Adverse Events and Serious Adverse Events
Time frame: Through 24 Months
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 7 Oct 2026.
- Individual participant dataSharing planned: Undecided. At the time of study registration, the sponsor has not yet determined whether de-identified individual participant data (IPD) will be made available to other researchers. Any future decisions regarding data sharing will consider participant privacy, informed consent provisions, applicable regulatory requirements, and sponsor policies. If a data-sharing plan is established, the ClinicalTrials.gov record will be updated accordingly.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Triojection® System and Selective Nerve Root Block (SNRB) in people with Lumbar Radiculopathy and Lumbar Disc Herniation, run by SpinaFX Medical Inc..
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 9 inclusion and 46 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite Clinical Success at 6 Months (time frame: 6 Months). 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 7 Oct 2026.