🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-07-30)

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

🟢 Recruiting Protocol / Phase N/A ⚙️ Medical Device Protocol Sponsor: ReGelTec, Inc.

🩺 Protocol Summary

A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.

Primary Research Facility: Alabama Clinical Therapeutics (Birmingham, Alabama)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Degenerative Disc Disease (DDD)?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged between 22 Years and 85 Years?

🔍 Protocol Specified Age Range: 22 Years to 85 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 15 Registered Participating Sites

📍 Primary Site Map

Site: Alabama Clinical Therapeutics — Birmingham, Alabama

📍 All Participating Trial Locations (15 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Alabama Clinical Therapeutics — Birmingham, Alabama

2. Source Healthcare — Santa Monica, California

3. Boomerang Healthcare (IPM Medical Group) — Walnut Creek, California

4. DBPS Research (The Denver Spine & Pain Institute) — Greenwood Village, Colorado

5. The Orthopaedic Institute — Gainesville, Florida

6. Southwest Florida Pain Center — Port Charlotte, Florida

7. NRSA Group (Florida Spine & Pain Specialists) — Riverview, Florida

8. Tenet Florida Physician Services II (Cantor Spine Center at The Paley Orthopedic and Spine Institute) — West Palm Beach, Florida

9. Horizon Clinical Research (Southern Pain and Spine) — Jasper, Georgia

10. Neuroscience Research Center, LLC — Overland Park, Kansas

11. Spine Institute of Louisiana (The Spine Network) — Shreveport, Louisiana

12. Clinical Investigations — Edmond, Oklahoma

13. Precision Spine Care — Tyler, Texas

14. Virginia iSpine Physicians — Richmond, Virginia

15. Beam Research (Beam Radiology) — Calgary, Alberta

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06011551 • Last Synced: 2026-07-30

View on ClinicalTrials.gov ↗