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Clinical Trial Summary

VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.


Clinical Trial Description

The study will include adult subjects, ages 65 years and older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. Each subject will receive one injection per each affected level (max of 3 levels) and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 18 months, inclusive of enrollment and follow-up for all subjects. Subjects will be evaluated at baseline and followed through 6 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 26 weeks ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05412277
Study type Interventional
Source VIVEX Biologics, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date October 17, 2022
Completion date December 31, 2024

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