NCT05207813

CLBP Single-Arm Long-Term Follow-up Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients were originally enrolled under NCT03266107 and followed through 12-months post Intracept Procedure. This study approached patients from NCT03266107 to collect additional long-term effectiveness and satisfaction outcomes at three (3), four (4), and five (5) years post Intracept Procedure.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DEVICE	Intracept Procedure	Intraosseous Basivertebral Nerve (BVN) Ablation

Timeline

• Start date: 2022-02-16
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-01-26
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study