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临床试验/NCT05122611
NCT05122611已完成不适用

Post Lumbar Radiofrequency Neurotomy Imaging

FUSMobile Inc.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
MRI imaging of the lumbar spine

研究概览

简要总结

MRI imaging post radio frequency ablation procedure for facet arthritis

详细描述

This study is an imaging study. Following a radio frequency ablation procedure for facet arthritis low back pain the patient can join the imaging study.

During the study the patient undergo contrast enhanced MRI imaging of the lumbar spine Once the imaging is done the patient finishes the study

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male and females, legally able and willing to participate in the study
  • Able and willing to complete the research questionnaires and communicate with the investigator and research team
  • Patients who are scheduled to have bilateral or unilateral treatment by radiofrequency neurotomy for chronic lumbar pain.

排除标准

  • Pregnant or breastfeeding patient
  • Patients younger than 18
  • Patients unable to understand and complete the research questionnaires in English
  • Patient with any contraindication for MRI contrast agents - Patients with known intolerance or allergies to the MRI contrast agent (e.g., Gadovist) including advanced kidney disease
  • Patients with a pacemaker, implanted defibrillator or internal pacing wires.
  • Patient with mechanical heart valve
  • Patient with an aneurysm clip
  • Patient with eye surgery or injury involving a metallic object
  • Patient with ear surgery or implanted device to the ear
  • Patient with any implanted electrical, metallic or magnetic device such as implanted neurostimulator, implanted drug infusion pump or bone growth stimulator
  • Patient with any kind of prosthesis (Eye, Ear, Penile, limb), or any other metal in your body from surgery or injury
  • Patient with vascular clamp, filter, coil or stent
  • Pregnant or breast-feeding patient
  • Patient with anemia, liver disease or history of MRI contrast reaction
  • Patient with any known kidney disease, prior kidney surgery or on dialysis
  • Patient with hypertension or diabetes that requires medication
  • Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup)
  • Patients who are claustrophobic or known adverse psychological reactions with previous MRI

结局指标

主要结局

MRI imaging of the lumbar spine

时间窗: Up to 5 days after the RFA procedure (which was done before the study)

MRI imaging of the lumbar spine

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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