Discogenic PainNCT06345690
VIA Disc NP Registry 3.0
An observational study of Discogenic Pain and Back Pain, run by VIVEX Biologics, Inc. at 24 sites in United States.
Trial summary
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Discogenic Pain, Back Pain, Back Pain, Low
- What is being tested?
- VIA Disc NP
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 24 sitesUnited States
- Study dates
- 27 Feb 2024to 1 Jan 2027
- How long will I take part?
- 12 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants diagnosed with and treated for back pain.
Who may be able to join
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- 18 years of age or older
- Literate, able to speak and read English, and able to complete questionnaires independently
- Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.
Who cannot join
- Participant did not receive VIA Disc NP injection
- Participant is pregnant (self-reported, no special study pregnancy testing needed).
- Any contraindications as noted in the VIA Disc NP Instructions for Use
- Previous treatment with VIA Disc NP
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Premier Pain Solutions
Asheville, North Carolina, 28803
Freedom Spine
Boerne, Texas, 78006
Specialists in Pain Managment
Chattanooga, Tennessee, 37404
Atlantic Coast Spine & Pain
Conway, South Carolina, 29526
Corpus Chrisi Pain Medicine
Corpus Christi, Texas, 78415
Align Interventional Pain
Edmond, Oklahoma, 73013
MD Pain
Englewood, Colorado, 80112
The Orthopedic Research Foundation, Inc.
Fishers, Indiana, 46278
The Orthopedic Institute
Gainesville, Florida, 32605
Western Rockies Interventional Pain
Grand Junction, Colorado, 81505
Renew Pain Solutions
Greenville, South Carolina, 29607
Comprehensive Pain Consultants of the Carolinas
Hendersonville, North Carolina, 28791
Horizon Clinical Research
Jasper, Georgia, 30143
Raso Pain Center
Jupiter, Florida, 33477
Mocek Spine
Little Rock, Arkansas, 72205
Crystal Coast Pain Management
Morehead City, North Carolina, 28557
Crystal Coast Pain Management
New Bern, North Carolina, 28560
Interventional Pain Specialists - Pain Clinic
Opelousas, Louisiana, 70570
Advanced Spine and Pain Center
San Antonio, Texas, 78240
Paradigm Health System
Slidell, Louisiana, 70461
Pain and Wellness Institute of Texas
Spring Branch, Texas, 80700
Premier Spine and Pain Institute
Thornton, Colorado, 80229
Precision Spine Care
Tyler, Texas, 75701
Interventional Spine Care of the Palm Beaches
West Palm Beach, Florida, 33407
About this study
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
Read the detailed description
The Registry is intended to collect data for patients having received treatment with VIA Disc NP.
- Conditions
- Discogenic Pain, Back Pain, Back Pain, Low
- Being tested
- VIA Disc NP
- Keywords
- Back Pain
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIA Disc NPOther
VIA Disc NP - Allograft tissue injection
| Study group | Role | What they receive |
|---|---|---|
| VIA Disc NP | Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment Receives: Other: VIA Disc NP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
Measured: 1, 3, 6, & 12 months
Oswestry Disability Index (ODI)
Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain.
Measured: 1, 3, 6, & 12 months
Patient Satisfaction
Patient reported assessment of treatment regarding their experience with the procedure. Four different responses, which range from Not at all satisfied (worst) to Extremely Satisfied (best).
Measured: 1, 3, 6, & 12 months
Frequency of Pain Medication Use
Assesses the frequency and type of pain medication administered to participants at baseline and follow-up visits scheduled at 1, 3, 6, and 12 months. Data will be collected to track changes in pain medication usage over time.
Measured: 1, 3, 6, & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start27 Feb 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discogenic PainStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- VIVEX Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie Zaccari, Study director, Sponsor - Vivex Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345690
- Sponsor's protocol ID
- VIA-2023-003
- Status last verified
- May 2026
- First submitted
- 6 Mar 2024
- Last updated
- 12 May 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIA Disc NP Registry 3.0
- ClinicalTrials.gov ID
- NCT06345690
- Acronym / sponsor ID
- VIA-2023-003
- Conditions
- Discogenic Pain, Back Pain, Back Pain, Low
- Keywords
- Back Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- VIVEX Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Apr 2024 (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.
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
Detailed description
The Registry is intended to collect data for patients having received treatment with VIA Disc NP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIA Disc NP | – | Other: VIA Disc NPPatients meeting study criteria receiving Vivex VIA Disc NP injection as treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with and treated for back pain.
Key inclusion criteria (4 listed)
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- 18 years of age or older
- Literate, able to speak and read English, and able to complete questionnaires independently
- Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.
Key exclusion criteria (4 listed)
- Participant did not receive VIA Disc NP injection
- Participant is pregnant (self-reported, no special study pregnancy testing needed).
- Any contraindications as noted in the VIA Disc NP Instructions for Use
- Previous treatment with VIA Disc NP
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 |
|---|---|---|
| VIA Disc NPVIA Disc NP - Allograft tissue injection | Other | VIA Disc NP |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 1, 3, 6, & 12 months
Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
Oswestry Disability Index (ODI)
Time frame: 1, 3, 6, & 12 months
Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain.
Patient Satisfaction
Time frame: 1, 3, 6, & 12 months
Patient reported assessment of treatment regarding their experience with the procedure. Four different responses, which range from Not at all satisfied (worst) to Extremely Satisfied (best).
Frequency of Pain Medication Use
Time frame: 1, 3, 6, & 12 months
Assesses the frequency and type of pain medication administered to participants at baseline and follow-up visits scheduled at 1, 3, 6, and 12 months. Data will be collected to track changes in pain medication usage over time.
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 12 May 2026.
- Individual participant dataSharing planned: No
Related trials for Discogenic Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Active, not recruitingPhase 2
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Recruiting
Discogen for Low Back Pain
Disc Herniation
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
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. This study is not recruiting at the moment.
Leslie Zaccari study director
Sponsor - Vivex Biologics
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Discogenic Pain and Back Pain, run by VIVEX Biologics, Inc. at 24 sites in United States.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. 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?
Numeric Pain Rating Scale (NPRS) (time frame: 1, 3, 6, & 12 months). The study lists 4 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 12 May 2026.