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HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

NCT06011551 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-05-08

No results posted yet for this study

Summary

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

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)

Sponsors & Collaborators

  • ReGelTec, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Beall, MD · Clinical Investigations LLC

  • Kasra Amirdelfan, MD · IPM Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2027-11-30
Completion
2028-11-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011551 on ClinicalTrials.gov