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临床试验/NCT06477965
NCT06477965招募中不适用

Multicenter National Registry for Artery Embolization (Embo Registry) for the Treatment of Osteoarthritis and Areas of Localized Pain to Assess Treatment of Artery Embolization to Determine If Subjects Have Decrease Pain, Decreased Use of Narcotics and NSAIDs, and Quality of Life Improvement Post Procedure.

Vascular Solutions of North Carolina2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
2
主要终点
Primary Outcome

研究概览

简要总结

Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

详细描述

Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes. The embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. Tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. This reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment. For the study to determine efficacy and overall improvement of patients post procedure by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale (VAS) scores, Western Ontario and McMaster Universities Index (WOMAC), EQ-5D-5L Quality of Life Questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • > 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain.

排除标准

  • 未提供

结局指标

主要结局

Primary Outcome

时间窗: 3 months

Clinical success at 3 months, as defined by improvement in the quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline.

次要结局

  • Secondary Outcome(12 months)

研究者

发起方
Vascular Solutions of North Carolina
申办方类型
Other
责任方
Sponsor

研究点 (2)

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