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Fibrin Sealant
Fibrin for Chronic Multi-level Discogenic Low Back Pain
Phase 2 & 3
Waitlist Available
Led By Kevin Pauza, MD
Research Sponsored by Pauza, Kevin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if injecting a protein called fibrin into the spine can help people with serious chronic low back pain by repairing damaged tissues and reducing pain.
Eligible Conditions
- Spinal Radiculopathy
- Degenerative Disc Disease
- Low Back Pain
- Radiculopathy
- Lower Back Pain
- Disc Disease
- Annular Disc Tear
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Oswestry Disability Index (ODI)
Secondary study objectives
EURO Quality of Life (EuroQol)
North American Spine Society (NASS) for patient satisfaction
Numeric Rating Scale (NRS)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fibrin GroupExperimental Treatment1 Intervention
Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fibrinogen human
FDA approved
Find a Location
Who is running the clinical trial?
Pauza, Kevin, MDLead Sponsor
Kevin Pauza, MDPrincipal InvestigatorINTERVENTIONAL SPINE SPECIALIST