VIA Disc NP Pilot for Patients With Symptomatic Degenerated Discs

Status Active, not recruiting

Clinical Trial Summary

VIA Disc NP is an allograph intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Clinical Trial Description

The study will include adult subjects, ages 18 years or older, with symptomatic lumbar intervertebral disc degeneration 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 24 month observation period. The study is expected to be completed within 26 months, inclusive of enrollment and follow-up for all subjects. Subjects will be evaluated at baseline and followed through 24 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 104 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05201287
Study type	Interventional
Source	VIVEX Biologics, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 30, 2021
Completion date	July 31, 2024

View Details

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