VIA Disc NP Registry

July 18, 2023 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

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)

10000

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 Backup

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Withdrawn
        • Gateway Pain Solutions
    • California
      • Santa Monica, California, United States, 90403
        • Terminated
        • Source Healthcare
      • Walnut Creek, California, United States, 94598
        • Terminated
        • Interventional Pain Management
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Recruiting
        • MD Pain
        • Contact:
        • Principal Investigator:
          • Donald J Bernardini, MD
      • Grand Junction, Colorado, United States, 81505
        • Recruiting
        • Western Rockies Interventional Pain Specialists
        • Contact:
          • Kenneth Lewis, MD
          • Phone Number: 970-270-2259
        • Principal Investigator:
          • Kenneth Lewis, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Terminated
        • International Spine, Pain & Performance Center
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • The Orthopedic Institute
        • Principal Investigator:
          • Ajay Antony, MD
        • Contact:
      • Port Charlotte, Florida, United States, 33948
        • Recruiting
        • Southwest Florida Pain Center
        • Contact:
        • Principal Investigator:
          • Robert Ball, MD
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Florida Spine & Pain Specialists
        • Principal Investigator:
          • Nomen Azeem, MD
        • Contact:
      • Tampa, Florida, United States, 33609
        • Terminated
        • FAST MD
      • Wesley Chapel, Florida, United States, 33544
    • Indiana
      • Indianapolis, Indiana, United States, 46278
        • Terminated
        • Orthopaedic Research Foundation
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Anesthesiology & Pain Consultants
        • Contact:
        • Principal Investigator:
          • James Rabalais, MD
    • Michigan
      • Brownstown, Michigan, United States, 48183
        • Withdrawn
        • Michigan Interventional Pain Center
      • Ypsilanti, Michigan, United States, 48198
        • Terminated
        • Forest Health
    • Nevada
      • Reno, Nevada, United States, 89511
        • Withdrawn
        • Nevada Advanced Pain Specialists
    • New York
      • New York, New York, United States, 10022
        • Terminated
        • Ainsworth Institute of Pain Management
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Premier Pain Solutions
        • Contact:
        • Principal Investigator:
          • Javid Baksh, MD
      • New Bern, North Carolina, United States, 28560
        • Recruiting
        • Crystal Coast Pain Management
        • Contact:
        • Principal Investigator:
          • Kirk E Harum, MD
    • Ohio
      • Loveland, Ohio, United States, 45140
        • Terminated
        • Premier Pain
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Terminated
        • Invictus Healthcare System
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Withdrawn
        • Center for Interventional Pain Spine
    • South Carolina
      • Conway, South Carolina, United States, 29526
        • Recruiting
        • Atlantic Coast Pain Management
        • Contact:
        • Principal Investigator:
          • Blake Kline, MD
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Specialist in Pain Management
        • Contact:
        • Principal Investigator:
          • John E Blake, MD
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Vertex Spine
        • Contact:
        • Principal Investigator:
          • Matthew P Rupert, MD
    • Texas
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Advanced Spine and Pain Center
        • Contact:
          • Sofia Sued, MD
          • Phone Number: 210-690-0777
        • Principal Investigator:
          • Ellen Lin, MD
      • Shenandoah, Texas, United States, 77384
        • Recruiting
        • The Sprintz Center for Pain
        • Contact:
        • Principal Investigator:
          • Yoann Millet, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Registry will include at least 10,000 patients diagnosed with and treated for back pain across approximately 200 selected sites.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • VIA Disc NP injection is not performed

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VIA Disc NP
Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment
Biological: VIA Disc NP
VIA Disc NP - Allograft tissue injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1, 3, 6, 12, 24, & 36 months
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.
1, 3, 6, 12, 24, & 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self-reported mental health
Time Frame: 1, 3, 6, 12, 24, & 36 months
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).
1, 3, 6, 12, 24, & 36 months
Resource Utilization
Time Frame: 1, 3, 6, 12, 24, & 36 months
Patient reported assessment of healthcare and resources utilized questions to treat ongoing back pain post treatment.
1, 3, 6, 12, 24, & 36 months

Collaborators and Investigators

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

Sponsor

VIVEX Biologics, Inc.

Collaborators

Talosix

Investigators

  • Study Director: Lisa Finstein, MHA, 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)

May 3, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIV-001-020

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

product manufactured in and exported from the U.S.

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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