HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
ConditionDegenerative Disc Disease (DDD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-85
SponsorReGelTec, Inc.
About this trial
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
Eligibility criteria
Qualifiers
Male or female subjects aged 22 to 85 years, inclusive
Subjects presenting with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration
Presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by Discography
Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI
Disqualifiers
History of or active systemic or local infection
Any skin disease or inadequate tissue coverage at the site of the proposed injection
Annular tear or defect that shows free contrast extravasation into the epidural space during or after Discography
Presence of more than two (2) symptomatic discs presenting with pain confirmed during Discography
Trial design
Treatments tested in this trial
- The ReGelTec HYDRAFIL™ System
- Conservative Care Management
Treatment groups
225 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov