Condition: Degenerative Disc Disease · Disc Degeneration · Lumbar Discogenic Pain · Sponsor: VIVEX Biologics, Inc.
VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.
This description comes directly from the study's public registry record.
Leslie Zaccari · 714-366-6457 · lzaccari@vivex.com
Always discuss trial participation with your own doctor first.
| Interventional Pain Management Napa Valley Orthopedic Medical Group | Napa, California, United States | Recruiting |
| Source Healthcare | Santa Monica, California, United States | Recruiting |
| Premier Spine and Pain Institute | Thornton, Colorado, United States | Recruiting |
| The Orthopaedic Institute | Gainesville, Florida, United States | Recruiting |
| Georgia Pain Management | Woodstock, Georgia, United States | Recruiting |
| Henry Community Health | New Castle, Indiana, United States | Recruiting |
| University of Kansas | Kansas City, Kansas, United States | Recruiting |
| University of Kentucky | Lexington, Kentucky, United States | Recruiting |
| Ochsner Clinic Foundation | New Orleans, Louisiana, United States | Recruiting |
| Spine Institute of Louisiana | Shreveport, Louisiana, United States | Recruiting |
| Paradigm Health System | Slidell, Louisiana, United States | Recruiting |
| Nevada Advanced Pain Specialists | Reno, Nevada, United States | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06778447