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临床试验/NCT04258319
NCT04258319Enrolling By Invitation不适用

Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema

Mayo Clinic3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Mayo Clinic
入组人数
90
试验地点
3
主要终点
Viscoelasticity parameters with lymphedema as obtained using the SAVE method

研究概览

简要总结

Researchers are trying to validate the use of ultrasound sub-hertz analysis of viscoelastisty (SAVE) method to monitor tissue-fluid dynamics and stage disease severity in patients diagnosed with lymphedema.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • Adult (18+ years of age)
  • Ability to provide written consent
  • Has been diagnosed with Lymphedema

排除标准

  • Under the age of 18 years old
  • Inability to provide written consent
  • Previous lymphovenous bypass or lymph node transfer surgery

研究组 & 干预措施

Affected (Lymphedema)

Experimental

Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

干预措施: Ultrasound Procedure (Diagnostic Test)

Unaffected (Control)

Active Comparator

Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure

干预措施: Ultrasound Procedure (Diagnostic Test)

结局指标

主要结局

Viscoelasticity parameters with lymphedema as obtained using the SAVE method

时间窗: Baseline

Defined as the difference in viscoelastic parameters between the arm affected with lymphedema and the unaffected extremity (affected minus unaffected) using the sub-hertz analysis of viscoelasticity method

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio J. Forte

Principal Investigator

Mayo Clinic

研究点 (3)

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