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Device

HYDRAFIL for Back Pain Due to Degenerative Disc Disease

N/A
Waitlist Available
Led By Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP
Research Sponsored by ReGelTec, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 and 24 months
Awards & highlights

Summary

This trial is testing a new treatment for back pain caused by degenerative disc disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Success
Secondary outcome measures
Back pain as measured by NRS
Function as measured by ODI
Safety of the ReGelTec Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise

Trial Design

1Treatment groups
Experimental Treatment
Group I: HYDRAFIL ImplantExperimental Treatment1 Intervention
Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs

Who is running the clinical trial?

ReGelTec, Inc.Lead Sponsor
1 Previous Clinical Trials
225 Total Patients Enrolled
Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPPPrincipal InvestigatorBeam Interventional & Diagnostic Imaging

Media Library

HYDRAFIL (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04984629 — N/A
Degenerative Disc Disease Research Study Groups: HYDRAFIL Implant
Degenerative Disc Disease Clinical Trial 2023: HYDRAFIL Highlights & Side Effects. Trial Name: NCT04984629 — N/A
HYDRAFIL (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984629 — N/A
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT04984629 — N/A
~11 spots leftby Nov 2025