VIA Disc NP Registry 3.0
1 other identifier
observational
500
1 country
26
Brief Summary
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2024
CompletedFirst Submitted
Initial submission to the registry
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
April 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
February 6, 2026
February 1, 2026
2.8 years
March 6, 2024
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Numeric Pain Rating Scale (NPRS)
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)
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
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
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
Study Arms (1)
VIA Disc NP
Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment
Interventions
Eligibility Criteria
Participants diagnosed with and treated for back pain.
You may qualify if:
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- years of age or older
- Literate, able to speak and read English, and able to complete questionnaires independently
- Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.
You may not qualify if:
- Participant did not receive VIA Disc NP injection
- Participant is pregnant (self-reported, no special study pregnancy testing needed).
- Any contraindications as noted in the VIA Disc NP Instructions for Use
- Previous treatment with VIA Disc NP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Mocek Spine
Little Rock, Arkansas, 72205, United States
MD Pain
Englewood, Colorado, 80112, United States
Western Rockies Interventional Pain
Grand Junction, Colorado, 81505, United States
The Denver Spine & Pain Institute
Greenwood Village, Colorado, 80111, United States
Premier Spine and Pain Institute
Thornton, Colorado, 80229, United States
The Orthopedic Institute
Gainesville, Florida, 32605, United States
Raso Pain Center
Jupiter, Florida, 33477, United States
Interventional Spine Care of the Palm Beaches
West Palm Beach, Florida, 33407, United States
Horizon Clinical Research
Jasper, Georgia, 30143, United States
The Orthopedic Research Foundation, Inc.
Fishers, Indiana, 46278, United States
Interventional Pain Specialists - Pain Clinic
Opelousas, Louisiana, 70570, United States
Paradigm Health System
Slidell, Louisiana, 70461, United States
Premier Pain Solutions
Asheville, North Carolina, 28803, United States
Comprehensive Pain Consultants of the Carolinas
Hendersonville, North Carolina, 28791, United States
Crystal Coast Pain Management
Morehead City, North Carolina, 28557, United States
Crystal Coast Pain Management
New Bern, North Carolina, 28560, United States
Align Interventional Pain
Edmond, Oklahoma, 73013, United States
Fox Chase Pain Management_Delaware Valley Pain and Spine Institute (DVPSI)
Trevose, Pennsylvania, 19053, United States
Atlantic Coast Spine & Pain
Conway, South Carolina, 29526, United States
Renew Pain Solutions
Greenville, South Carolina, 29607, United States
Specialists in Pain Managment
Chattanooga, Tennessee, 37404, United States
Freedom Spine
Boerne, Texas, 78006, United States
Corpus Chrisi Pain Medicine
Corpus Christi, Texas, 78415, United States
Advanced Spine and Pain Center
San Antonio, Texas, 78240, United States
Pain and Wellness Institute of Texas
Spring Branch, Texas, 80700, United States
Precision Spine Care
Tyler, Texas, 75701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Leslie Zaccari
Sponsor - Vivex Biologics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2024
First Posted
April 3, 2024
Study Start
February 27, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share