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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 is a NA study of Degenerative Disc Disease (DDD) that is actively recruiting participants, run by ReGelTec. The registered enrollment target is 225 participants. The trial reports 12 study locations across 10 states.
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.
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 |
Interested in This Trial?
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, categorized as NA. 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.
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 reports 12 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Related
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