Basivertebral Nerve Ablation With the Intracept Procedure
NCT05692440 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2024-03-21
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.
Conditions
- Low Back Pain
Interventions
- DEVICE
-
Intracept Procedure
Intraosseous radiofrequency ablation of the basivertebral nerve
Sponsors & Collaborators
-
Neuro Spine and Pain Center of Key West
lead OTHER
Principal Investigators
-
William Schnapp, PhD · Owner
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 84 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-03
- Primary Completion
- 2026-01-01
- Completion
- 2026-06-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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