VIA Disc NP Registry

NCT04652687 | Terminated

• 1 other identifier: VIV-001-020
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 32

Brief Summary

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

Conditions

Discogenic Pain; Back Pain; Back Pain, Low

Keywords

back pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Patient self-reported mental health

  1, 3, 6, 12, 24, & 36 months

• Resource Utilization

  1, 3, 6, 12, 24, & 36 months

Study Arms (1)

VIA Disc NP

Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment

Other: VIA Disc NP (HCT/P)

Interventions

VIA Disc NP (HCT/P) OTHER

VIA Disc NP - Allograft tissue injection

VIA Disc NP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• VIA Disc NP injection is not performed

Sponsors & Collaborators

• VIVEX Biologics, Inc.: lead

Study Sites (32)

Gateway Pain Solutions

Mesa, Arizona, 85206, United States

Location

Source Healthcare

Santa Monica, California, 90403, United States

Location

Interventional Pain Management

Walnut Creek, California, 94598, United States

Location

MD Pain

Englewood, Colorado, 80112, United States

Location

Western Rockies Interventional Pain Specialists

Grand Junction, Colorado, 81505, United States

Location

The Denver Spine & Pain Institute

Greenwood Village, Colorado, 80111, United States

Location

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, 20006, United States

Location

The Orthopedic Institute

Gainesville, Florida, 32607, United States

Location

Southwest Florida Pain Center

Port Charlotte, Florida, 33948, United States

Location

FAST MD

Tampa, Florida, 33609, United States

Location

Florida Spine & Pain Specialists

Tampa, Florida, 33614, United States

Location

Florida Pain Medicine

Wesley Chapel, Florida, 33544, United States

Location

Orthopaedic Research Foundation

Indianapolis, Indiana, 46278, United States

Location

Anesthesiology & Pain Consultants

Lafayette, Louisiana, 70508, United States

Location

Interventional Pain Specialists

Opelousas, Louisiana, 70570, United States

Location

Michigan Interventional Pain Center

Brownstown, Michigan, 48183, United States

Location

Forest Health

Ypsilanti, Michigan, 48198, United States

Location

Nevada Advanced Pain Specialists

Reno, Nevada, 89511, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Premier Pain Solutions

Asheville, North Carolina, 28803, United States

Location

Crystal Coast Pain Management

New Bern, North Carolina, 28560, United States

Location

Premier Pain

Loveland, Ohio, 45140, United States

Location

Invictus Healthcare System

Tulsa, Oklahoma, 74133, United States

Location

Center for Interventional Pain Spine

Chadds Ford, Pennsylvania, 19317, United States

Location

Atlantic Coast Pain Management

Conway, South Carolina, 29526, United States

Location

Southeastern Spine Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

Specialist in Pain Management

Chattanooga, Tennessee, 37404, United States

Location

Vertex Spine

Franklin, Tennessee, 37067, United States

Location

Ortho Spine Surgery Institute

North Richland Hills, Texas, 76182, United States

Location

MD SpineCare and DC Medical Solutions

San Antonio, Texas, 78229, United States

Location

Advanced Spine and Pain Center

San Antonio, Texas, 78258, United States

Location

The Sprintz Center for Pain

Shenandoah, Texas, 77384, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Finstein, MHA

  Vivex Biologics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: December 3, 2020
• Study Start: May 3, 2020
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)