Status:
COMPLETED
INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
Lead Sponsor:
Relievant Medsystems, Inc.
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participant...
Detailed Description
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-...
Eligibility Criteria
Inclusion
- Skeletally mature subjects at least 25 years of age
- Chronic lower back pain for at least 6 months
- Failure to respond to at least 6 months of non-operative conservative management
Exclusion
- Radicular pain
- Current or history of spinal infection
- Modic changes at vertebral bodies other than L3 to S1
- Contraindication to MRI
- Pregnant, lactating or plan to become pregnant in next year
- Has life expectancy of less than 2 years
- Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03246061
Start Date
August 24 2017
End Date
March 5 2024
Last Update
April 2 2024
Active Locations (18)
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1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
2
Barrow Brain and Spine
Phoenix, Arizona, United States, 85048
3
Keck Medicine of USC
Los Angeles, California, United States, 90033
4
Stanford Orthopaedic Surgery
Redwood City, California, United States, 94063