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

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

VIVEX Biologics, Inc.

Collaborators

Moxie Clinical

Investigators

  • 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)

February 27, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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