VIA Disc NP Registry 3.0

May 7, 2026 updated by: VIVEX Biologics, Inc.
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Registry is intended to collect data for patients having received treatment with VIA Disc NP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Mocek Spine
    • Colorado
      • Englewood, Colorado, United States, 80112
        • MD Pain
      • Grand Junction, Colorado, United States, 81505
        • Western Rockies Interventional Pain
      • Thornton, Colorado, United States, 80229
        • Premier Spine and Pain Institute
    • Florida
      • Gainesville, Florida, United States, 32605
        • The Orthopedic Institute
      • Jupiter, Florida, United States, 33477
        • Raso Pain Center
      • West Palm Beach, Florida, United States, 33407
        • Interventional Spine Care of the Palm Beaches
    • Georgia
      • Jasper, Georgia, United States, 30143
        • Horizon Clinical Research
    • Indiana
      • Fishers, Indiana, United States, 46278
        • The Orthopedic Research Foundation, Inc.
    • Louisiana
      • Opelousas, Louisiana, United States, 70570
        • Interventional Pain Specialists - Pain Clinic
      • Slidell, Louisiana, United States, 70461
        • Paradigm Health System
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Premier Pain Solutions
      • Hendersonville, North Carolina, United States, 28791
        • Comprehensive Pain Consultants of the Carolinas
      • Morehead City, North Carolina, United States, 28557
        • Crystal Coast Pain Management
      • New Bern, North Carolina, United States, 28560
        • Crystal Coast Pain Management
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Align Interventional Pain
    • South Carolina
      • Conway, South Carolina, United States, 29526
        • Atlantic Coast Spine & Pain
      • Greenville, South Carolina, United States, 29607
        • Renew Pain Solutions
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Specialists in Pain Managment
    • Texas
      • Boerne, Texas, United States, 78006
        • Freedom Spine
      • Corpus Christi, Texas, United States, 78415
        • Corpus Chrisi Pain Medicine
      • San Antonio, Texas, United States, 78240
        • Advanced Spine and Pain Center
      • Spring Branch, Texas, United States, 80700
        • Pain and Wellness Institute of Texas
      • Tyler, Texas, United States, 75701
        • Precision Spine Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with and treated for back pain.

Description

Inclusion Criteria:

  1. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
  2. 18 years of age or older
  3. Literate, able to speak and read English, and able to complete questionnaires independently
  4. Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.

Exclusion Criteria:

  1. Participant did not receive VIA Disc NP injection
  2. Participant is pregnant (self-reported, no special study pregnancy testing needed).
  3. Any contraindications as noted in the VIA Disc NP Instructions for Use
  4. Previous treatment with VIA Disc NP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
VIA Disc NP
Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment
Other: VIA Disc NP
VIA Disc NP - Allograft tissue injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1, 3, 6, & 12 months
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.
1, 3, 6, & 12 months
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).
1, 3, 6, & 12 months
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.
1, 3, 6, & 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VIVEX Biologics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Moxie Clinical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Leslie Zaccari, Sponsor - Vivex Biologics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIA-2023-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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