Open-Label, Single-Arm, Single-Center Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:25 - 70
Updated:11/3/2018
Start Date:February 28, 2018
End Date:December 2019
Contact:Thuy Olender
Email:tolender@relievant.com
Phone:650-368-1000

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Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Objective of study is to evaluate the procedural success rate, clinical effectiveness, and
health-economic profile of using the Intracept Intraosseous Nerve Ablation System in adult
subjects with chronic low back pain in the post-market setting

This is a prospective, open-label, single-arm, single-center study. There is no randomization
or blinding. Subjects will receive the Intracept System procedure to treat one or two motion
segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
Seton Spine & Scoliosis Center
Austin, Texas 78731
Principal Investigator: Eeric Truumees, MD
Phone: 512-324-3580
?
mi
from
Austin, TX
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