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Fibrin for Chronic Multi-level Discogenic Low Back Pain

NCT04621799 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-11-09

No results posted yet for this study

Summary

Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).

Conditions

  • Low Back Pain
  • Disc Disease
  • Disc Degeneration
  • Radiculopathy
  • Annular Disc Tear

Interventions

DRUG

Fibrin sealant

The intra-annular delivery of non-autologous fibrin into the annulus

Sponsors & Collaborators

  • Pauza, Kevin, MD

    lead OTHER

Principal Investigators

  • Kevin Pauza, MD · INTERVENTIONAL SPINE SPECIALIST

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2020-12-31
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04621799 on ClinicalTrials.gov