HYDRAFIL for Degenerative Disc Disease (HYDRAFIL-D Trial)

N/A

Recruiting

Led By Douglas Beall, MD

Research Sponsored by ReGelTec, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI

The presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by discography

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month

Summary

This trial will assess how safe and effective the ReGelTec HYDRAFIL™ System is through a study involving multiple centers, two groups, and randomization.

Who is the study for?

This trial is for men and women aged 22-85 with lower back pain due to degenerative disc disease, confirmed by MRI and discography. Participants must have tried conservative care for six months without relief, be able to follow the study's procedures, complete forms, and speak English fluently.

What is being tested?

The HYDRAFIL-D trial is testing the ReGelTec HYDRAFIL™ System against standard conservative care management in patients with degenerative disc disease. It's a multi-center study where participants are randomly assigned to one of these two approaches.

What are the potential side effects?

Potential side effects of the ReGelTec HYDRAFIL™ System may include discomfort at injection site, allergic reactions to materials used in the system or increased back pain. Conservative care typically has minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My MRI shows I have moderate to severe disc degeneration.

Select...

I have 1 or 2 spinal discs causing symptoms, confirmed by a disc test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Endpoint of Clinical Success

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment ArmExperimental Treatment2 Interventions

Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the "Treatment Arm")

Group II: Control ArmPlacebo Group1 Intervention

Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to inside the skin in the direction of the target disc(s) but without contacting the muscle layer or deeper (the "Control Arm")

0 / 2Eligibility criteria met