Status:
COMPLETED
Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain
Lead Sponsor:
Relievant Medsystems, Inc.
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
Detailed Description
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept Sys...
Eligibility Criteria
Inclusion
- Skeletally mature subjects at least 25 years of age
- Chronic low back pain for at least 6 months
- Failure to respond to at least 6 months of non-operative conservative management
- Oswestry Disability Index (ODI) at least 30 points
- Modic changes Type 1 or 2
Exclusion
- Current or history of vertebral cancer or spinal metastasis
- History of a fragility fracture
- Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- Disc extrusion or protrusion
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03266107
Start Date
February 14 2018
End Date
February 17 2020
Last Update
December 22 2020
Active Locations (2)
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1
Indiana Spine Group
Carmel, Indiana, United States, 46032
2
Seton Spine and Scoliosis Center
Austin, Texas, United States, 78731