Safety and Effectiveness Study of the AO-1000 Device to Treat Contained Herniated Discs

NCT01339377 | Completed Phase 1

• 1 other identifier: CT2-IPP-001-AO
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Disk, Herniated

Keywords

Ozone; Oxygen; Oxygen-Ozone; AO-1000; ActiveO; Herniated Disc; Disc; Lumbar

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint: Change from Baseline ODI Score at 1 Month

  Mean change from baseline ODI score, analyzed at 1 month. The endpoint will be deemed successful if the mean improvement is statistically shown (p\<0.05) to be at least 15 points (the minimum detectable change of the ODI).

  1 month post-treatment

• Primary Safety Endpoint: Frequency of Serious Adverse Events Compared to Literature Control

  The endpoint will be deemed successful if the number of serious device/procedure related adverse events are statistically shown (p\<0.05) to be no greater than those in a literature control of other percutaneous disc decompression procedures.

  12 months post-treatment

Secondary Outcomes (4)

• Functional improvement

  6 and 12 months post-treatment

• Leg and Back Pain Improvement

  1, 6, and 12 months post-treatment

• Procedural Success

  Time of Treatment

• Analgesic Medication Use

  1, 6, and 12 months post-treatment

Study Arms (1)

AO-1000 Treatment

EXPERIMENTAL

Oxygen-ozone treatment with the AO-1000 device

Device: AO-1000

Interventions

AO-1000 DEVICE

Mixture of 2 weight% ozone in 98 weight% oxygen injected into the nucleus pulposus of a contained herniated disc.

AO-1000 Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age
• Herniated disc between L1 and S1 evident on diagnostic imaging
• Sciatica with or without lower back pain for \> 3 months
• Failure to improve with non-operative care (Conservative treatment failure)
• Sciatica with or without lower back pain exacerbated by sitting and/or standing with recumbent relief
• A preoperative leg or back VAS (pain) score between 40 and 90 mm on a 100 mm scale. (moderate to severe pain)
• A preoperative ODI (function) score between 40 and 90 (moderate to severe functional disability)
• Able and willing to return for the follow-up evaluations
• The pain must be consistent with the dermatome pattern and must be clearly identifiable to the herniated disc.

You may not qualify if:

• Functional neurological deficit evident during neurological exam
• Previous spine surgery in the lumbar region or adjacent to the disc of interest
• Cord compression or cauda equine syndrome
• Structural deformities (e.g. spondylolisthesis, greater than a mild degree of non-discogenic vertebral canal stenosis, greater than a mild degree of scoliosis, spinal fracture, disc herniations \> 4 mm, sequestered herniation)
• Extruded/free disc fragment
• Calcified disc fragment
• Disc height loss \> 75%
• Inaccessible disc due to, for example, overlap of the iliac wings, and/or steep angulation of the L5/S1 disc space
• Coagulopathy evident on blood sample testing
• Platelet count \< 50,000
• International Normalized Ratio (INR) \> 1.4
• Partial Thromboplastin Time (PTT) \> 1.3
• White blood cell count (WBCC) \> 12,000
• Infection as evidenced by subject clinical evaluation, history, and blood test
• Any evidence of osteomyelitis/discitis at any level

Sponsors & Collaborators

• ActiveO Inc.: lead

Study Sites (3)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of Western Ontario - London Health Sciences Centre

London, Ontario, N6H 5A5, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (8)

• Steppan J, Meaders T, Muto M, Murphy KJ. A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs. J Vasc Interv Radiol. 2010 Apr;21(4):534-48. doi: 10.1016/j.jvir.2009.12.393. Epub 2010 Feb 25.

  PMID: 20188591 BACKGROUND

• Pellicanò G, Martinelli F, Tavanti V, et al. The Italian Oxygen-Ozone Therapy Federation (FIO) Study on Oxygen-Ozone Treatment of Herniated Disc. Int J Ozone Ther 6:7-15, 2007.

  BACKGROUND

• Oder B, Loewe M, Reisegger M, Lang W, Ilias W, Thurnher SA. CT-guided ozone/steroid therapy for the treatment of degenerative spinal disease--effect of age, gender, disc pathology and multi-segmental changes. Neuroradiology. 2008 Sep;50(9):777-85. doi: 10.1007/s00234-008-0398-2. Epub 2008 May 16.

  PMID: 18483728 BACKGROUND

• Mixter WJ, Barr JS. Rupture of the intervertebral disc with involvement of the spinal canal. N Engl J Med 211:210-215, 1934.

  BACKGROUND

• Andreula CF, Simonetti L, De Santis F, Agati R, Ricci R, Leonardi M. Minimally invasive oxygen-ozone therapy for lumbar disk herniation. AJNR Am J Neuroradiol. 2003 May;24(5):996-1000.

  PMID: 12748111 BACKGROUND

• Andreula C, Muto M, Leonardi M. Interventional spinal procedures. Eur J Radiol. 2004 May;50(2):112-9. doi: 10.1016/j.ejrad.2003.10.013.

  PMID: 15081127 BACKGROUND

• Bonetti M, Fontana A, Cotticelli B, Volta GD, Guindani M, Leonardi M. Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back pain: randomized controlled study. AJNR Am J Neuroradiol. 2005 May;26(5):996-1000.

  PMID: 15891150 BACKGROUND

• Gallucci M, Limbucci N, Zugaro L, Barile A, Stavroulis E, Ricci A, Galzio R, Masciocchi C. Sciatica: treatment with intradiscal and intraforaminal injections of steroid and oxygen-ozone versus steroid only. Radiology. 2007 Mar;242(3):907-13. doi: 10.1148/radiol.2423051934. Epub 2007 Jan 5.

  PMID: 17209164 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 20, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

CA (3)