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Clinical Trial Summary

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

Clinical Trial Description

The study will include adult subjects, ages 18 years or older, with symptomatic mild to moderate Degenerative Disc Disease (DDD) that is not adequately resolved by non-surgical standard care. For the purpose of the primary analysis, subjects are considered enrolled in the study once they have signed the informed consent. Each subject will receive one injection per level and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 8 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 NCT05201287
Study type Interventional
Source Vivex Biomedical, Inc.
Contact Lisa Finstein
Phone 6039212524
Email [email protected]
Status Recruiting
Phase Early Phase 1
Start date December 30, 2021
Completion date July 31, 2023

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