VIA Disc NP Registry

Terminated

• Conditions: Back Pain; Discogenic Pain; Back Pain, Low

• Registration Number: NCT04652687
• Lead Sponsor: VIVEX Biologics, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-05-03
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-03
• Primary Completion: 2024-03-05
• Study Completion: 2024-03-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 83

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient self-reporting of daily function	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.
Patient self-reported back pain	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).

Secondary Outcome Measures

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

Trial Locations

Locations (32)

Gateway Pain Solutions; 🇺🇸 Mesa, Arizona, United States

Source Healthcare; 🇺🇸 Santa Monica, California, United States

Interventional Pain Management; 🇺🇸 Walnut Creek, California, United States

MD Pain; 🇺🇸 Englewood, Colorado, United States

Western Rockies Interventional Pain Specialists; 🇺🇸 Grand Junction, Colorado, United States

The Denver Spine & Pain Institute; 🇺🇸 Greenwood Village, Colorado, United States

International Spine, Pain & Performance Center; 🇺🇸 Washington, District of Columbia, United States

The Orthopedic Institute; 🇺🇸 Gainesville, Florida, United States

Southwest Florida Pain Center; 🇺🇸 Port Charlotte, Florida, United States

FAST MD; 🇺🇸 Tampa, Florida, United States

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