Basivertebral Nerve Ablation With the Intracept Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2026-06-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Basivertebral Nerve Ablation

Intraosseous radiofrequency basivertebral nerve ablation

Group Type OTHER

Intracept Procedure

Intervention Type DEVICE

Intraosseous radiofrequency ablation of the basivertebral nerve

Interventions

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Intracept Procedure

Intraosseous radiofrequency ablation of the basivertebral nerve

Intervention Type DEVICE

Eligibility Criteria

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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.