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NCT06011551 · ClinicalTrials.gov registry record · NA
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
A NA study of Degenerative Disc Disease (DDD), sponsored by ReGelTec.
- Recruiting
- Registry status
- NA
- Development phase
- 225
- Enrollment target
- 12
- Study locations
NCT06011551: Recruiting NA study of Degenerative Disc Disease (DDD), sponsored by ReGelTec.
NCT06011551 is a NA study of Degenerative Disc Disease (DDD) that is actively recruiting participants, run by ReGelTec. The registered enrollment target is 225 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06011551, a NA study of Degenerative Disc Disease (DDD), is actively recruiting participants, sponsored by ReGelTec.
- RECRUITING
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
- 12
- Study locations
Study Summary
A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
Primary Outcome
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.
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 |
What NCT06011551 shows while recruiting
NCT06011551 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
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.
NCT06011551 lists 12 locations in 10 states (California, Florida, Alabama).
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).
What interventions are being tested in trial NCT06011551?
The interventions under investigation include: The ReGelTec HYDRAFIL™ System (DEVICE), Conservative Care Management (OTHER).
Who is sponsoring clinical trial NCT06011551?
This trial is sponsored by ReGelTec, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease (DDD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06011551's enrollment target sits among peer trials
225 472nd of 2000 higher than 1,523 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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