Intracept Intraosseous Basivertebral Nerve Ablation

Utah System of Higher Education (USHE)

Status: Active, not recruiting

Conditions: Low Back Pain

Treatments: Procedure: Intracept Procedure

Study type: Observational

Funder types: Other

Identifiers

NCT05660512

130205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients scheduled for intraosseous basivertebral nerve ablation with the Intracept Procedure
• OR Participant had an Intracept Procedure for their low back pain and completed standard of care questionnaires at their procedure appointment.

Exclusion criteria

• Not scheduled for an intraosseous basivertebral nerve ablation with the Intracept Procedure
• Intracept procedure for different location other than low back pain