Safety and Effectiveness Study of the AO-1000 Device to Treat Contained Herniated Discs
Condition: Disk, Herniated
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and effectiveness of the AO-1000 device to treat and relieve the pain
      of symptomatic subjects with contained herniated discs. This single-arm pilot study will be
      used as a go vs. no-go decision on performing a randomized-controlled trial.

      The study's primary effectiveness objective is to demonstrate that the patient's
      functionality (based on Oswestry Disability Index scores) has improved from baseline at one
      month. The study's primary safety objective is to demonstrate that serious device/procedure
      related adverse events and subsequent surgical interventions are no greater than those in a
      literature control of other percutaneous disc decompression procedures at discharge, 1 month,
      6 months, and 12 months post-treatment.

      Secondary objectives are to demonstrate procedural success and improvement in the pain and
      function of the subjects at 1, 6, and 12 months using the VAS and ODI scales as well as
      tracking analgesic medication use. Pain and function scores for each follow-up time will be
      compared to the baseline scores.
    

Detailed description: 
      The AO-1000 device provides an oxygen-ozone treatment for contained herniated discs. An
      oxygen-ozone treatment is a minimally invasive injection for treating disc herniations that
      is widely practiced in Europe and Asia. This treatment involves the injection of an
      oxygen-ozone mixture into the herniated disc and/or the paravertebral muscle surrounding the
      disc. However, there are no medical ozone generators for this procedure that are currently
      cleared by the FDA for use in the US. Many studies using a wide range of inclusion/exclusion
      criteria, ozone concentrations, and procedures have been performed to determine the
      effectiveness of oxygen-ozone treatment.

      A meta-analysis of nearly 8,000 patients from published studies shows a mean improvement of
      39 mm for VAS and 25.7 for ODI. The likelihood of complications was 0.064%. Furthermore, no
      cases of discitis were reported after oxygen-ozone therapy, which is unlike all the other
      methods of disc volume reduction. This is most likely due to the fact that ozone is a strong
      oxidizer and an excellent disinfecting agent. The complications shown in the meta-analysis
      were minor and transient, and easily avoidable by utilizing a device such as the AO-1000 that
      is designed to eliminate these types of complications (ozone leakage into the treatment room
      and high ozone concentrations) during this procedure. The estimated complication rate from
      the meta-analysis is consistent with the Italian Oxygen-Ozone Therapy Federation (FIO)
      results (no procedure-related adverse events in treatments on 15,000 patients).

      The safety of the direct injection of oxygen-ozone gas mixture into the nucleus pulposus was
      well established in these studies. Therefore, the intent of this study is to obtain data to
      confirm that a 2 weight percent (wt%) oxygen-ozone mixture delivered from the AO-1000 device
      is safe and effective for the intended use. This clinical study is designed to bridge the
      AO-1000 to the extensive prior oxygen-ozone treatment safety and effectiveness data between
      studies such as those found in the Meta-analysis that did not use the AO-1000 as the delivery
      system.
    

Intervention name(s): AO-1000
Intervention type(s): Device
Intervention description(s): Mixture of 2 weight% ozone in 98 weight% oxygen injected into the nucleus pulposus of a contained herniated disc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ozone; Oxygen; Oxygen-Ozone; AO-1000; ActiveO; Herniated Disc; Disc; Lumbar