CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Intracept Proceduredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05207813
NCT05207813N/ACompleted
CompareCT.gov

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

Boston Scientific Corporation·observational·Posted Jan 26, 2022·Updated May 8, 2025

In Brief

An observational study evaluating Intracept Procedure for Chronic Low Back Pain. Completed, enrolled 42 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 26, 2022
Enrollment StartFeb 16, 2022
Primary CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.4 years ago

Interventions

Intracept Proceduredevice

Intraosseous Basivertebral Nerve (BVN) Ablation