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HYDRAFIL for Degenerative Disc Disease

Beam Interventional & Diagnostic Imaging, Calgary, Canada
Degenerative Disc DiseaseHYDRAFIL - Device
Eligibility
22 - 80
All Sexes

Study Summary

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

Video Summary

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 3, 6, 12 and 24 months

Month 24
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
Month 12
Back Pain as Measured by NRS Scale
Function
post-treatment
Success

Trial Safety

Phase-Based Safety

1 of 3

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2
TGplPTH1-34 in fibrin
2
BRTX-100
3
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

HYDRAFIL Implant
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: HYDRAFIL · No Placebo Group · N/A

HYDRAFIL Implant
Device
Experimental Group · 1 Intervention: HYDRAFIL · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 12 and 24 months

Who is running the clinical trial?

ReGelTec, Inc.Lead Sponsor
Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPPPrincipal InvestigatorBeam Interventional & Diagnostic Imaging

Eligibility Criteria

Age 22 - 80 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your symptoms have not improved after trying pain medication and/or physical therapy for 12 weeks.
You have been experiencing lower back pain and symptoms of degenerative disc disease in your lower spine for at least 6 months.
You have back pain that rates at least 4 out of 10 on a pain scale and your daily activities are limited due to the pain.

Who else is applying?

What state do they live in?
California21.4%
Pennsylvania7.1%
Alabama7.1%
Other64.3%
How old are they?
18 - 6568.4%
65+31.6%
What site did they apply to?
Beam Interventional & Diagnostic Imaging100.0%
What portion of applicants met pre-screening criteria?
Met criteria83.7%
Did not meet criteria16.3%
Why did patients apply to this trial?
  • "COMPLETE DESPERATION & HOPELESSNESS…"
  • "I’m am DESPERATE and I’ve tried everything…."
  • "Dealing with back pain and not wanting surgery."
  • "Low back pain for 2 plus years, very painful and affecting quality of life."
  • "I have had a lumbar fusion (l5/s1) but continue to have diffuse lumbar pain due to DDD."
How many prior treatments have patients received?
013.6%
19.1%
29.1%
3+68.2%
What questions have other patients asked about this trial?
  • "When will the trial begin?"
  • "When is the trial taking place?"
  • "How many screening visits are required?"
  • "Will trials eventually be held in the New York City area?"
  • "How long to visits take and how often would I need to come back for checkups?"

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Beam Interventional & Diagnostic Imaging: < 48 hours
Average response time
  • < 2 Days
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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