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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
Present with predominant low back pain and symptoms of DDD of the lumbar region of at least 6 months duration.
Failure to have their symptoms resolve or reduce following 12 weeks conservative care (pain medication and/or physical therapy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 and 24 months
Awards & highlights

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been experiencing lower back pain and other symptoms of degenerative disc disease in your lower spine for at least six months.
Select...
Your symptoms have not improved after trying pain medication and/or physical therapy for 12 weeks.
Select...
You have severe back pain that rates at least 4 out of 10 on a scale, and it impacts your ability to do daily activities, which is measured by the Oswestry Disability Index score of at least 30.
Select...
You have been experiencing lower back pain and symptoms of degenerative disc disease in your lower spine for at least 6 months.
Select...
Your symptoms did not improve or get better after trying pain medication and/or physical therapy for 6 months.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept participants aged 80 or above?

"This medical trial has a strict age requirement, with the minimum being 22 and the maximum being 80."

Answered by AI

What criteria must individuals meet to participate in this research?

"This clinical trial has a limited pool of participants, with the desired age range being between 22 and 80. To be eligible to participate in this study, individuals must have intervertebral disc degeneration. The research is seeking 50 volunteers overall."

Answered by AI

Are there still open opportunities for individuals to join this research project?

"Clinicaltrials.gov indicates that this medical trial, initially published on April 1st 2022 and recently updated on October 25th 2022, is not currently accepting patients. With the exception of this study, however, there are 62 other ongoing studies recruiting participants right now."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
Florida
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Beam Interventional & Diagnostic Imaging
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+

What questions have other patients asked about this trial?

Are we the first? When do trials begin? When can I get started? When will the trial begin?
PatientReceived 1 prior treatment
How long does each visit take?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

COMPLETE DESPERATION & HOPELESSNESS…. I have followed your info for 3 years.
PatientReceived 2+ prior treatments
I’m getting desperate, nothings helping! I've tried everything and I don't improve.
PatientReceived no prior treatments
I’m am DESPERATE and I’ve tried everything….
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Beam Interventional & Diagnostic Imaging: < 48 hours
~14 spots leftby Nov 2025