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CLBP Single-Arm Long-Term Follow-up Study

NCT05207813 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2025-05-08

Study results available
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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.

Conditions

  • Chronic Low Back Pain

Interventions

DEVICE

Intracept Procedure

Intraosseous Basivertebral Nerve (BVN) Ablation

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Natalie Bloom Lyons · Boston Scientific Corporation

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2024-02-01
Completion
2024-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207813 on ClinicalTrials.gov