Discogenic PainNCT04652687
VIA Disc NP Registry
An observational study of Discogenic Pain and Back Pain, run by VIVEX Biologics, Inc. at 32 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 (HCT/P)
- Type of treatment
- Injection or infusion
- How many people
- 83 participants
- Where
- 32 sitesUnited States
- Study dates
- 3 May 2020to 5 Mar 2024
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Registry will include at least 10,000 patients diagnosed with and treated for back pain across approximately 200 selected sites.
Who may be able to join
- 18 years of age or older
- Understand and sign the informed consent form (as applicable)
- VIA Disc NP injection is scheduled for 1 or more levels
Who cannot join
- VIA Disc NP injection is not performed
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Premier Pain Solutions
Asheville, North Carolina, 28803
Michigan Interventional Pain Center
Brownstown, Michigan, 48183
Center for Interventional Pain Spine
Chadds Ford, Pennsylvania, 19317
Specialist in Pain Management
Chattanooga, Tennessee, 37404
Atlantic Coast Pain Management
Conway, South Carolina, 29526
MD Pain
Englewood, Colorado, 80112
Vertex Spine
Franklin, Tennessee, 37067
The Orthopedic Institute
Gainesville, Florida, 32607
Western Rockies Interventional Pain Specialists
Grand Junction, Colorado, 81505
The Denver Spine & Pain Institute
Greenwood Village, Colorado, 80111
Orthopaedic Research Foundation
Indianapolis, Indiana, 46278
Anesthesiology & Pain Consultants
Lafayette, Louisiana, 70508
Premier Pain
Loveland, Ohio, 45140
Gateway Pain Solutions
Mesa, Arizona, 85206
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464
Crystal Coast Pain Management
New Bern, North Carolina, 28560
Ainsworth Institute of Pain Management
New York, New York, 10022
Ortho Spine Surgery Institute
North Richland Hills, Texas, 76182
Interventional Pain Specialists
Opelousas, Louisiana, 70570
Southwest Florida Pain Center
Port Charlotte, Florida, 33948
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
MD SpineCare and DC Medical Solutions
San Antonio, Texas, 78229
Advanced Spine and Pain Center
San Antonio, Texas, 78258
Source Healthcare
Santa Monica, California, 90403
The Sprintz Center for Pain
Shenandoah, Texas, 77384
FAST MD
Tampa, Florida, 33609
Florida Spine & Pain Specialists
Tampa, Florida, 33614
Invictus Healthcare System
Tulsa, Oklahoma, 74133
Interventional Pain Management
Walnut Creek, California, 94598
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, 20006
Florida Pain Medicine
Wesley Chapel, Florida, 33544
Forest Health
Ypsilanti, Michigan, 48198
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 (HCT/P)
- 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 NP (HCT/P)Other
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 (HCT/P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-reporting of daily function
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, 24, & 36 months
Patient self-reported back pain
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, 24, & 36 months
Secondary outcomes (2)
Patient self-reported mental health
Change in patient reported anxiety and depression scores. Four question scale used for patient self-reporting of anxiety and depression which ranges from 0-2 (normal), mild (3-5), moderate (6-8), and severe (9-12).
Measured: 1, 3, 6, 12, 24, & 36 months
Resource Utilization
Patient reported assessment of healthcare and resources utilized questions to treat ongoing back pain post treatment.
Measured: 1, 3, 6, 12, 24, & 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start3 May 2020
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Why it stopped: Sponsor decision.
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
- 83 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- VIVEX Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652687
- Sponsor's protocol ID
- VIV-001-020
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2020
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIA Disc NP Registry
- ClinicalTrials.gov ID
- NCT04652687
- Acronym / sponsor ID
- VIV-001-020
- Conditions
- Discogenic Pain, Back Pain, Back Pain, Low
- Keywords
- back pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- VIVEX Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2020 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 3 Dec 2020 (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
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIA Disc NP | – | Other: VIA Disc NP (HCT/P)Patients 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
- Registry will include at least 10,000 patients diagnosed with and treated for back pain across approximately 200 selected sites.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Understand and sign the informed consent form (as applicable)
- VIA Disc NP injection is scheduled for 1 or more levels
Key exclusion criteria (1 listed)
- VIA Disc NP injection is not performed
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 NP (HCT/P)VIA Disc NP - Allograft tissue injection | Other | VIA Disc NP |
Primary outcome
Patient self-reporting of daily function
Time frame: 1, 3, 6, 12, 24, & 36 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 self-reported back pain
Time frame: 1, 3, 6, 12, 24, & 36 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).
2 secondary outcomes
Patient self-reported mental health
Time frame: 1, 3, 6, 12, 24, & 36 months
Resource Utilization
Time frame: 1, 3, 6, 12, 24, & 36 months
Results and safety
The study was stopped early (reason given: Sponsor decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Discogenic Pain
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ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
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Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
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Recruiting
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 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 32 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 3 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: stopped early, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
The study was stopped early (reason given: Sponsor decision.). Results are not available in the source record.
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?
Patient self-reporting of daily function (time frame: 1, 3, 6, 12, 24, & 36 months). 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 6 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.