RecruitingNot ApplicableNCT06011551

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Sponsor

ReGelTec, Inc.

Enrollment

225 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

Degenerative Disc Disease (DDD)

Summary

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

Eligibility

Min Age: 22 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Conservative Care Management and a medical device called The ReGelTec HYDRAFIL™ System for people with degenerative disc disease (ddd). The study is currently recruiting participants at 14 locations. People eligible for this study include aged 22 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThe ReGelTec HYDRAFIL™ System

The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.

OTHERConservative Care Management

Conservative care management (including physical therapy and/or pain medication)

Locations(15)

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Source Healthcare

Santa Monica, California, United States

Boomerang Healthcare (IPM Medical Group)

Walnut Creek, California, United States

DBPS Research (The Denver Spine & Pain Institute)

Greenwood Village, Colorado, United States

The Orthopaedic Institute

Gainesville, Florida, United States

Southwest Florida Pain Center

Port Charlotte, Florida, United States

NRSA Group (Florida Spine & Pain Specialists)

Riverview, Florida, United States

Tenet Florida Physician Services II (Cantor Spine Center at The Paley Orthopedic and Spine Institute)

West Palm Beach, Florida, United States

Horizon Clinical Research (Southern Pain and Spine)

Jasper, Georgia, United States

Neuroscience Research Center, LLC

Overland Park, Kansas, United States

Spine Institute of Louisiana (The Spine Network)

Shreveport, Louisiana, United States

Clinical Investigations

Edmond, Oklahoma, United States

Precision Spine Care

Tyler, Texas, United States

Virginia iSpine Physicians

Richmond, Virginia, United States

Beam Research (Beam Radiology)

Calgary, Alberta, Canada

View Full Details on ClinicalTrials.gov

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NCT06011551

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