NCT06011551

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: ReGelTec, Inc. · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Degenerative Disc Disease (DDD)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-01-13
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2023-08-25
• Last updated: 2026-02-03

Locations

12 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study