Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01339377
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2011-04-19
Brief Title:
Safety and Effectiveness Study of the AO-1000 Device to Treat Contained Herniated Discs
Sponsor:
ActiveO Inc
Organization:
ActiveO Inc
Study Overview
Official Title:
A Pilot Study to Evaluate the Safety and Effectiveness of Ozone Generated and Injected by the AO-1000 Device in the Treatment of Contained Herniated Discs
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studys primary effectiveness objective is to demonstrate that the patients functionality based on Oswestry Disability Index scores has improved from baseline at one month The studys primary safety objective is to demonstrate that serious deviceprocedure 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
The studys primary effectiveness objective is to demonstrate that the patients functionality based on Oswestry Disability Index scores has improved from baseline at one month The studys primary safety objective is to demonstrate that serious deviceprocedure 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 andor 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 inclusionexclusion criteria ozone concentrations and procedures have been performed to determine the effectiveness of oxygen-ozone treatment
A meta-analysis of nearly 8000 patients from published studies shows a mean improvement of 39 mm for VAS and 257 for ODI The likelihood of complications was 0064 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 15000 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
A meta-analysis of nearly 8000 patients from published studies shows a mean improvement of 39 mm for VAS and 257 for ODI The likelihood of complications was 0064 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 15000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None