NCT05660512

Intracept Intraosseous Basivertebral Nerve Ablation

A Prospective Single Arm Cohort Study of Intraosseous Basivertebral Nerve Ablation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed description

The Investigator Sponsor will initially approach patients planning to undergo the Intracept Procedure to discuss their interest in learning more about the study. With patient permission, contact information will be forwarded to a third-party research organization which will contact the patient to explain more about the study and to gather Verbal Informed Consent. Study data will be collected by the University of Utah research staff via 4 telephone study visits under the direction of the Sponsor Investigator. The study research staff will enter the study data directly into a study database and issue the subject stipend after the completion of each study visit. Data will be analyzed by a statistician under the direction of the Sponsor Investigator for this single-site study.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Intracept Procedure	Radiofrequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain

Timeline

• Start date: 2020-07-27
• Primary completion: 2026-02-05
• Completion: 2026-07-01
• First posted: 2022-12-21
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States