Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:25 - 70
Updated:11/7/2018
Start Date:August 24, 2017
End Date:September 2020
Contact:Thuy Olender
Email:tolender@relievant.com
Phone:650-368-1000

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INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Subjects will be randomized 1:1 Radio Frequency (RF) Ablation arm vs Control arm; this is an
open-label trial. Subjects in the the RF Ablation arm will receive the Intracept System
procedure to treat up to 4 vertebral bodies (L3 to S1). Subjects in the Control arm will
continue on non-surgical management therapies to treat their chronic low back pain (CLBP) and
will be offered optional crossover after 12 months of follow-up.

Subjects in the RF Ablation arm will be followed for 24 months following treatment. RF
Ablation arm subjects will be approached to participate in a sub study of 3 additional years
of follow-up at their 24 month visit. Control arm subjects will be offered optional crossover
treatment after the 12 month follow-up visit and will be followed for an additional 6 months
following crossover.

Inclusion Criteria:

- 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 Criteria:

- 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
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