HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
Public ClinicalTrials.gov record NCT06011551. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
Study identification
- NCT ID
- NCT06011551
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
Device · Other
Eligibility (public fields only)
- Age range
- 22 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 13, 2025 (Actual)
- Primary completion
- Dec 31, 2027 (Estimated)
- Completion
- Dec 31, 2028 (Estimated)
- Last update posted
- Sep 18, 2026
2025 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | Recruiting |
| Source Healthcare | Santa Monica | California | 90403 | Recruiting |
| Boomerang Healthcare (IPM Medical Group) | Walnut Creek | California | 94598 | Recruiting |
| DBPS Research (The Denver Spine & Pain Institute) | Greenwood Village | Colorado | 80111 | Recruiting |
| International Spine, Pain & Performance Center and Mountain Spine & Pain | Washington D.C. | District of Columbia | 20006 | Active, not recruiting |
| The Orthopaedic Institute | Gainesville | Florida | 32607 | Recruiting |
| Southwest Florida Pain Center | Port Charlotte | Florida | 33948 | Recruiting |
| NRSA Group (Florida Spine & Pain Specialists) | Riverview | Florida | 33569 | Recruiting |
| Tenet Florida Physician Services II (Cantor Spine Center at The Paley Orthopedic and Spine Institute) | West Palm Beach | Florida | 33407 | Recruiting |
| Horizon Clinical Research (Southern Pain and Spine) | Jasper | Georgia | 30143 | Recruiting |
| Neuroscience Research Center, LLC | Overland Park | Kansas | 66210 | Recruiting |
| Spine Institute of Louisiana (The Spine Network) | Shreveport | Louisiana | 71101 | Recruiting |
| Clinical Investigations | Edmond | Oklahoma | 73103 | Recruiting |
| Precision Spine Care | Tyler | Texas | 75701 | Recruiting |
| Virginia iSpine Physicians | Richmond | Virginia | 23238 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06011551, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2026 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06011551 live on ClinicalTrials.gov.