DiscSealTM Clinical Study
SpineOvations is conducting a prospective, single-arm feasibility clinical study in up to 10 subjects to investigate the safety, tolerability, and exploratory efficacy of DiscSealTM for the treatment of degenerative and diseased Intervertebral Disc (IVD) of the lumbar spine. The trial is being conducted in Australia at up to three clinical study sites. Study subjects will receive DiscSealTM treatment with follow-up visits through 180 days from initial treatment.
The primary objective objective of this study is to evaluate the safety of the DiscSealTM in the treatment of low back pain for patients with Discogenic Disease (including Degenerative Disc Disease (DDD), Internal Disc Disruption (IDD), and/or nonspecific discogenic disease) of the lumbar spine during the first 90 days following treatment. The secondary objective of this study is to determine device tolerability and to explore preliminary efficacy of DiscSealTM in the treatment of low back pain.
Secondary efficacy endpoints include:
- Improvement of Visual Analogue Scale (VAS) pain score
- Improvement in Oswestry Disability Index (ODI)
- Improvement in Clinical Global Impression of Change (CGI-c)
- Improvement in Patient Global Impression of Change (PGI-c)
SpineOvations intends to report the results of the study mid-2020.