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NCT04652687 Clinical Trial

VIA Disc NP Registry

Back Pain Clinical Trial

Official title:
VIA Disc NP Registry

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04652687
Other study ID # VIV-001-020
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 3, 2020
Est. completion date March 5, 2024

Study information
Verified date May 2024
Source VIVEX Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Terminated
Enrollment 83
Est. completion date March 5, 2024
Est. primary completion date March 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• VIA Disc NP (HCT/P)
VIA Disc NP - Allograft tissue injection

Locations
Country Name City State
United States Premier Pain Solutions Asheville North Carolina
United States Michigan Interventional Pain Center Brownstown Michigan
United States Center for Interventional Pain Spine Chadds Ford Pennsylvania
United States Specialist in Pain Management Chattanooga Tennessee
United States Atlantic Coast Pain Management Conway South Carolina
United States MD Pain Englewood Colorado
United States Vertex Spine Franklin Tennessee
United States The Orthopedic Institute Gainesville Florida
United States Western Rockies Interventional Pain Specialists Grand Junction Colorado
United States The Denver Spine & Pain Institute Greenwood Village Colorado
United States Orthopaedic Research Foundation Indianapolis Indiana
United States Anesthesiology & Pain Consultants Lafayette Louisiana
United States Premier Pain Loveland Ohio
United States Gateway Pain Solutions Mesa Arizona
United States Southeastern Spine Institute Mount Pleasant South Carolina
United States Crystal Coast Pain Management New Bern North Carolina
United States Ainsworth Institute of Pain Management New York New York
United States Ortho Spine Surgery Institute North Richland Hills Texas
United States Interventional Pain Specialists Opelousas Louisiana
United States Southwest Florida Pain Center Port Charlotte Florida
United States Nevada Advanced Pain Specialists Reno Nevada
United States Advanced Spine and Pain Center San Antonio Texas
United States MD SpineCare and DC Medical Solutions San Antonio Texas
United States Source Healthcare Santa Monica California
United States The Sprintz Center for Pain Shenandoah Texas
United States FAST MD Tampa Florida
United States Florida Spine & Pain Specialists Tampa Florida
United States Invictus Healthcare System Tulsa Oklahoma
United States Interventional Pain Management Walnut Creek California
United States International Spine, Pain & Performance Center Washington District of Columbia
United States Florida Pain Medicine Wesley Chapel Florida
United States Forest Health Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
VIVEX Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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