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Fibrin Sealant

Fibrin Group for Radiculopathy

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

Study Summary

This study is evaluating whether injections of fibrin may help reduce chronic low back pain.

Eligible Conditions
  • Radiculopathy
  • Lower Back Pain
  • Disc Disease
  • Disc Degeneration
  • Annular Disc Tear

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oswestry Disability Index (ODI)
Secondary outcome measures
EURO Quality of Life (EuroQol)
North American Spine Society (NASS) for patient satisfaction
Numeric Rating Scale (NRS)
+4 more

Side effects data

From 2014 Phase 4 trial • 256 Patients • NCT02034799
9%
Anemia
6%
Pyrexia
5%
Brain Oedema
2%
Lung Infection
1%
Glioma
1%
Postoperative Wound Infection
1%
Pneumonia
1%
Cerebral Ischaemia
1%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bioseal Fibrin Sealant
Standard of Care (SoC)

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Fibrin for Chronic Multi-level Discogenic Low Back Pain
2018. "Fibrin for Chronic Multi-level Discogenic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04621799.
All > Low Back Pain > Back Pain
~59 spots leftby Apr 2025
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