Clinical Trials Logo
  1. Home
  2. Degenerative Disc Disease (DDD)
  3. NCT06011551

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs — HYDRAFIL-D  

Degenerative Disc Disease (DDD) Clinical Trial

Official title:
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Clinical Trial Summary

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

Clinical Trial Description

This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial chronic low back pain (CLBP) due to degenerative disc disease (DDD) who continue to have severe back pain and dysfunction after at least six (6) months of conservative care. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06011551
Study type Interventional
Source ReGelTec, Inc.
Contact Robert Townsend
Phone 443-451-3915
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date January 2028
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00775801 - Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease N/A
Enrolling by invitation NCT02171169 - Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures N/A
Terminated NCT00374413 - Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD) N/A
Active, not recruiting NCT01551901 - Luna Interbody System for Fusion Trial N/A
Recruiting NCT05489822 - PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
Active, not recruiting NCT03737461 - Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive Phase 2/Phase 3
Enrolling by invitation NCT05536453 - Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine
Completed NCT01972256 - A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures N/A