CLBP Single-Arm Long-Term Follow-up Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-16

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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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

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Chronic Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Basivertebral nerve ablation treatment

Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study.

Intracept Procedure

Intervention Type DEVICE

Intraosseous Basivertebral Nerve (BVN) Ablation

Interventions

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Intracept Procedure

Intraosseous Basivertebral Nerve (BVN) Ablation

Intervention Type DEVICE

Eligibility Criteria

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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)"