Clinical Research Directory

Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation

Sponsor: Beam Research, Inc.

Summary

This study is retrospectively designed and aims to evaluate and summarize safety and performance data in eligible participants who have undergone Intradiscal ozone-oxygen injection for treatment of lumbar disc herniation with the Triojection® System in Canada under Special Access Program (SAP) between April 2022 and 31 March 2026 at one(1) participating site. The primary objectives of the study are : 1. To evaluate the clinical success in eligible participants who have undergone intradiscal ozone-oxygen injection procedure with the Triojection® System for treatment of lumbar disc herniation. 2. To evaluate the safety in eligible participants who have undergone the procedure. Retrospective data will be collected from existing medical records across three predefined periods: * Baseline, defined as within 180 days prior to treatment (index procedure); * Treatment, of variable duration, encompassing clinic admission, performance of the index procedure, post-procedure recovery, and discharge; * Follow-up, of variable duration, including any follow-up visits performed after discharge as part of the standard course of medical care. In addition, prospective data collection will be performed during a separate follow-up period of variable duration, consisting of follow-up visits conducted either remotely or in person to collect participant-reported outcomes including pain, function, work status, updated medical history, and medication use.

Official title: Safety and Performance of Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation - A Retrospective-Prospective Real-World Study.

Key Details

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Interventions

Locations (1)