Five-Plus Year Follow-Up of SMART Randomized Controlled Trial

Relievant Medsystems

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: Basivertebral Nerve (BVN) Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT03997825

CIP 0011

Details and patient eligibility

About

The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.

Full description

This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.

Enrollment: 117 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• LBP at least 6 months from original SMART Trial
• RF Ablation Arm from SMART Trial

Exclusion criteria

-Control Arm Subjects from SMART Trial

Trial design