Basivertebral Nerve Ablation With the Intracept Procedure

Neuro Spine and Pain Center of Key West

Status and phase: Invitation-only; Phase 4

Conditions: Low Back Pain

Treatments: Device: Intracept Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT05692440

20223348

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥18 years of age
• Patients who have experienced chronic low back pain for ≥6 months.
• Patients who have not responded to at least 6 months of conservative care.
• Patients with Modic type 1 or 2 changes.

Exclusion criteria

• Patients with severe cardiac or pulmonary disease.
• Patients with active systemic infection or localized infection in the treatment area.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Basivertebral Nerve Ablation

Other group

Description:

Intraosseous radiofrequency basivertebral nerve ablation

Treatment:

Device: Intracept Procedure