Study detail
RecruitingObservational
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
ReGelTec, Inc.
Summary
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
Description
This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial chronic low back pain (CLBP) due to degenerative disc disease (DDD) who continue to have severe back pain and dysfunction after at least six (6) months of conservative care.
Eligibility
- Age range
- 22–85 years
- Sex
- All
- Healthy volunteers
- No