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Recruiting NCT06827262

Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain

— Observational Chronic Low-back Pain Vertebrogenic Pain Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intracept™ Intraosseous Nerve Ablation.
Who it may be relevant to
Registry conditions: Chronic Low-back Pain, Vertebrogenic Pain Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Detailed description

The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.

Interventions

  • Device Intracept™ Intraosseous Nerve Ablation
    Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain

Primary outcome measures

  • Change in Disability (Oswestry Disability Index (ODI) from Baseline [Time frame: 60-months post-procedure]

Eligibility criteria

Inclusion criteria

  • Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
  • Signed a valid, IRB/EC-approved informed consent form.

Exclusion criteria

  • Meets any contraindications per locally applicable Instructions for Use (IFU).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 18 centers
  • Flagstaff Bone & Joint — Flagstaff
  • Innovative Pain and Wellness — Phoenix
  • MarinHealth Spine Institute — Larkspur
  • The Spine Wellness Center in Westport — Westport
  • Washington Hospital Center — Washington D.C.
  • Orlando Regional Medical Center — Orlando
  • North Idaho Day Surgery, LLC — Post Falls
  • Illinois Bone and Joint Institute — Barrington
  • … and 10 more centers

Identifiers

NCT: NCT06827262 · REL025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗