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HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
NCT06011551 · View on ClinicalTrials.gov ↗
Study Summary
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
Conditions Studied
Interventions
- DEVICE The ReGelTec HYDRAFIL™ System
- OTHER Conservative Care Management
Study Locations (12)
California
- Source Healthcare — Santa Monica
- Boomerang Healthcare (IPM Medical Group) — Walnut Creek
Florida
- Southwest Florida Pain Center — Port Charlotte
- NRSA Group (Florida Spine & Pain Specialists) — Riverview
Alabama
- Alabama Clinical Therapeutics — Birmingham
Colorado
- DBPS Research (The Denver Spine & Pain Institute) — Greenwood Village
Georgia
- Horizon Clinical Research (Southern Pain and Spine) — Jasper
Louisiana
- Spine Institute of Louisiana (The Spine Network) — Shreveport
Oklahoma
- Clinical Investigations — Edmond
Texas
- Precision Spine Care — Tyler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2025-01-13 |
| Est. Completion | 2028-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06011551
The ClinicalTrials.gov registry entry for NCT06011551 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ReGelTec, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Degenerative Disc Disease (DDD) appearing as the primary indexed condition, and to 2 interventions — of which The ReGelTec HYDRAFIL™ System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06011551 reports 12 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06011551 about?
NCT06011551 is a clinical study titled "HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs". A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
What is the current status of trial NCT06011551?
This trial is currently recruiting. It is a NA study. The enrollment target is 225 participants. The study started on 2025-01-13. Estimated completion is 2028-11.
What conditions does trial NCT06011551 study?
This clinical trial studies the following conditions: Degenerative Disc Disease (DDD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06011551?
The interventions under investigation include: The ReGelTec HYDRAFIL™ System (DEVICE), Conservative Care Management (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06011551?
This trial is sponsored by ReGelTec, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06011551 being conducted?
This trial has 12 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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