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Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation

NCT02525120 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-06-06

No results posted yet for this study

Summary

The primary objective of this study is to compare the early clinical outcomes following non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less than or equal to 6 months.

Conditions

  • Lumbar Disc Herniation

Interventions

DEVICE

Triojection

Triojection is system intended to deliver a specific amount of ozone to a herniated disc.

PROCEDURE

Surgical discectomy

Patients will receive surgery to remove the herniated disc material.

Sponsors & Collaborators

  • genae international,ag

    collaborator UNKNOWN

  • Minimus Spine, Inc

    lead OTHER

Principal Investigators

  • Josip Buric, MD · Centro Chirurgico San Paolo, Pistoia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-12-31
Completion
2020-05-31

Countries

  • Greece
  • Italy
  • Switzerland

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 NCT02525120 on ClinicalTrials.gov