VIA Disc NP Registry

Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.

Study Overview

• Status: Terminated
• Conditions: Back Pain; Discogenic Pain; Back Pain, Low
• Intervention / Treatment: Other: VIA Disc NP (HCT/P)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Gateway Pain Solutions
  • California
    • Santa Monica, California, United States, 90403
      • Source Healthcare
    • Walnut Creek, California, United States, 94598
      • Interventional Pain Management
  • Colorado
    • Englewood, Colorado, United States, 80112
      • MD Pain
    • Grand Junction, Colorado, United States, 81505
      • Western Rockies Interventional Pain Specialists
    • Greenwood Village, Colorado, United States, 80111
      • The Denver Spine & Pain Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • International Spine, Pain & Performance Center
  • Florida
    • Gainesville, Florida, United States, 32607
      • The Orthopedic Institute
    • Port Charlotte, Florida, United States, 33948
      • Southwest Florida Pain Center
    • Tampa, Florida, United States, 33614
      • Florida Spine & Pain Specialists
    • Tampa, Florida, United States, 33609
      • FAST MD
    • Wesley Chapel, Florida, United States, 33544
      • Florida Pain Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46278
      • Orthopaedic Research Foundation
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Anesthesiology & Pain Consultants
    • Opelousas, Louisiana, United States, 70570
      • Interventional Pain Specialists
  • Michigan
    • Brownstown, Michigan, United States, 48183
      • Michigan Interventional Pain Center
    • Ypsilanti, Michigan, United States, 48198
      • Forest Health
  • Nevada
    • Reno, Nevada, United States, 89511
      • Nevada Advanced Pain Specialists
  • New York
    • New York, New York, United States, 10022
      • Ainsworth Institute of Pain Management
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Premier Pain Solutions
    • New Bern, North Carolina, United States, 28560
      • Crystal Coast Pain Management
  • Ohio
    • Loveland, Ohio, United States, 45140
      • Premier Pain
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Invictus Healthcare System
  • Pennsylvania
    • Chadds Ford, Pennsylvania, United States, 19317
      • Center for Interventional Pain Spine
  • South Carolina
    • Conway, South Carolina, United States, 29526
      • Atlantic Coast Pain Management
    • Mount Pleasant, South Carolina, United States, 29464
      • Southeastern Spine Institute
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Specialist in Pain Management
    • Franklin, Tennessee, United States, 37067
      • Vertex Spine
  • Texas
    • North Richland Hills, Texas, United States, 76182
      • Ortho Spine Surgery Institute
    • San Antonio, Texas, United States, 78229
      • MD SpineCare and DC Medical Solutions
    • San Antonio, Texas, United States, 78258
      • Advanced Spine and Pain Center
    • Shenandoah, Texas, United States, 77384
      • The Sprintz Center for Pain

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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 (HCT/P); 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	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	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	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	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

• Sponsor: VIVEX Biologics, Inc.
• Collaborators: Talosix
• Investigators: Study Director: Lisa Finstein, MHA, Vivex Biologics

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2020
• Primary Completion (Actual): March 5, 2024
• Study Completion (Actual): March 5, 2024

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): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• 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