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临床试验/NCT06164392
NCT06164392撤回4 期

Evaluation of Neuroma Perfusion with Indocyanine Green Fluorescence Angiography

Northwestern University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年12月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
入组人数
25
试验地点
1
主要终点
Neuroma ICG Fluorescence Angiogram

研究概览

简要总结

The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography

详细描述

Neuromas represent the frustrated regeneration of injured nerve axons encased in a bulbous scar. Symptomatic neuromas are particularly problematic in patients with amputations. Targeted Muscle Reinnervation is a novel surgical approach to neuroma treatment, resulting in improved residual limb pain in amputees. Nevertheless, a subset of Targeted Muscle Reinnervation patients achieve inadequate relief. Incomplete neuroma excision may be of particular concern in such cases, as failure to completely excise the neuroma risks leaving a scarred proximal nerve stump behind. Despite the critical importance of complete neuroma excision, there is no clear definition of a neuroma's "zone of injury". Indeed, intraoperatively determining where to cut a nerve to ensure accurate and complete excision of a neuroma at the time of reconstruction or repair is an unsolved problem in peripheral nerve surgery. The proposed research aims to characterize the perfusion of neuromas using fluorescence angiography. Specifically, we will test the hypothesis that intravascular indocyanine green (ICG) renders visible the perturbations in nerve perfusion associated with neuromas, and that these altered perfusion patterns correlate with the nerve's "zone of injury" as identified by histopathology. Ultimately, indocyanine green (ICG) fluorescence angiography may facilitate intraoperative decision-making at the time of neuroma excision.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Age > 18 years
  • Clinical diagnosis of neuroma
  • Scheduled elective surgery for neuroma excision

排除标准

  • Minors, or age < 18 years old at the time of surgery
  • Unable to provide written, informed consent
  • Prisoners and decision-impaired individuals
  • Pregnant or lactating women
  • History of allergy to indocyanine green
  • History of allergy to iodides
  • History of allergic asthma
  • History of hepatic failure
  • History of renal failure
  • Patients in whom the planned surgical incision/approach does not include excision of the neuroma
  • Patients in whom adequate surgical exposure of the neuroma is unable to be obtained, as determined intraoperatively at the time of surgery by the Investigator or Co-Investigators
  • Any subject who, at the discretion of the Investigator or Co-Investigators, is not suitable for inclusion in the study

研究组 & 干预措施

Neuroma ICG

Experimental

Subjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma

干预措施: Indocyanine green (Drug)

结局指标

主要结局

Neuroma ICG Fluorescence Angiogram

时间窗: Intraoperative

Nerve Tissue Perfusion as visualized by Fluorescence Angiogram

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory A Dumanian

Chief of Plastic surgery in the Department of Surgery

Northwestern University

研究点 (1)

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