NCT04984629

Study of the ReGelTec HYDRAFIL System

Prospective, Single Arm, Non-randomized, Traditional Feasibility Study to Evaluate the Safety and Performance of the ReGelTec HYDRAFIL System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: ReGelTec, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A study designed to treat patients with back pain associated with degenerative lumbar disc disease.

Detailed description

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

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	HYDRAFIL	The HYDRAFIL System contains the following items: the Delivery System and the Pressure Gauge. The HYDRAFIL implant is contained within a pre-filled syringe that is inserted into the delivery system housing during the manufacturing process. The implant is heated within the delivery system prior to use to ensure a flowable implant that can be injected through a standard coaxial needle.

Timeline

• Start date: 2022-01-04
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2021-07-30
• Last updated: 2026-02-03

Locations

1 site across 1 country: Canada