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
This trial does not accept healthy volunteersQualifiers
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
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
Design model
Parallel
Treatments tested in this trial
The ReGelTec HYDRAFIL™ System
DeviceThe ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.
Conservative Care Management
Other interventionConservative care management (including physical therapy and/or pain medication)
Treatment groups
225 Participants
are divided into 3 treatment groupsGroup A: Treatment ArmExperimental treatment 2 interventions
Group B: Control ArmSham comparator 1 intervention
Group C: Crossover After 24M for Control Patient if QualifiedOther 2 interventions
Trial outcomes
Primary outcomes
1
Composite Endpoint of Clinical Success
The primary endpoint is a single composite endpoint reflecting five study outcomes (function, SAEs, SSIs, intercurrent events, and radiographic findings). The individual subject's outcome will be considered a success if all of the criteria are met at 12 months.
Time frame
12-monthSponsors and contacts
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Source ClinicalTrials.gov