Basivertebral Nerve Ablation With the Intracept Procedure

Status Enrolling by invitation

Clinical Trial Summary

This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.

Clinical Trial Description

Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months. Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05692440
Study type	Interventional
Source	Neuro Spine and Pain Center of Key West
Contact
Status	Enrolling by invitation
Phase	Phase 4
Start date	May 3, 2021
Completion date	June 1, 2026

View Details

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