CLBP Single-Arm Long-Term Follow-up Study

Boston Scientific

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: Intracept Procedure

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05207813

CP0015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 1 patient group

Basivertebral nerve ablation treatment

Description:

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

Treatment:

Device: Intracept Procedure