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CLBP Single-Arm Long-Term Follow-up Study

CompletedNCT05207813
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain Long-term Follow Up
Interventions
  • Device: Intracept Procedure
Sponsor
Boston Scientific Corporation
Start date
2022-02-16
Primary completion
2024-02-01
Sex
All
Age range
from 25 Years to 70 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: \- 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)" Exclusion Criteria: \- None

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05207813