CLBP Single-Arm Long-Term Follow-up Study

Completed

Conditions studied: Chronic Low Back Pain

In brief

This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study)" population at three (3), four (4), and five (5) years post Intracept Procedure. The working hypothesis is that data collected in this study will demonstrate safety, efficacy, durability and reproducibility of BVN ablation treatment outcomes out to 3, 4, and 5-years post-procedure.

Key facts

Study ID

NCT05207813

Run by

Boston Scientific Corporation

People needed

42

Starts

2022-02-16

Expected to finish

2024-02-01

Last updated by the study team

2025-05-08

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient received the Intracept procedure while participating in "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Long-Term Study)"

You may not qualify if…

• None

Where it is running

• Indiana Spine Group — Carmel, Indiana, United States
• Seton Healthcare Family — Austin, Texas, United States

Full record on ClinicalTrials.gov

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