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Study of the ReGelTec HYDRAFIL System

NCT04984629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-03

No results posted yet for this study

Summary

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

Conditions

  • Degenerative Disc Disease

Interventions

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.

Sponsors & Collaborators

  • ReGelTec, Inc.

    lead INDUSTRY

Principal Investigators

  • Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP · Beam Interventional & Diagnostic Imaging

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • 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 NCT04984629 on ClinicalTrials.gov