NCT06011551View on ClinicalTrials.gov

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

NARecruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

January 13, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

Conditions
Degenerative Disc Disease (DDD)
Interventions
DEVICE

The 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.

OTHER

Conservative Care Management

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

Trial Locations (10)

23238

RECRUITING

Virginia iSpine Physicians, Richmond

30143

RECRUITING

Horizon Clinical Research (Southern Pain and Spine), Jasper

33569

RECRUITING

NRSA Group (Florida Spine & Pain Specialists), Riverview

35235

RECRUITING

Alabama Clinical Therapeutics, Birmingham

71101

RECRUITING

Spine Institute of Louisiana (The Spine Network), Shreveport

73103

RECRUITING

Clinical Investigations, Edmond

75701

RECRUITING

Precision Spine Care, Tyler

80111

RECRUITING

DBPS Research (The Denver Spine & Pain Institute), Greenwood Village

94598

RECRUITING

Boomerang Healthcare (IPM Medical Group), Walnut Creek

T3R 0N2

RECRUITING

Beam Research (Beam Radiology), Calgary

All Listed Sponsors
lead

ReGelTec, Inc.

INDUSTRY