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

PHASE4UnknownINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 31, 2018

Study Completion Date

May 31, 2020

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.

Trial Locations (3)

6900

Ospedale Regionale di Lugano- Civico e Italiano, Lugano

12462

University General Hospital Attikon, Athens

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

genae international,ag

UNKNOWN

lead

Minimus Spine, Inc

OTHER