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临床试验/NCT05259995
NCT05259995已完成1 期

Verification of Performance of Sustained Acoustic Medicine Device Designs Diathermy

ZetrOZ, Inc.1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年2月21日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
Ultrasound Diathermy (Degrees Centigrade)

研究概览

简要总结

The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine Devices with commercially available ultrasound gel coupling patches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy Volunteer

排除标准

  • •Is pregnant/nursing.
  • •Has an active infection, open sores, or wounds in the treatment area.

研究组 & 干预措施

Sustained Acoustic Medicine Device Group 1

Experimental

Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

干预措施: Sustained Acoustic Medicine (Device)

Sustained Acoustic Medicine Device Group 2

Active Comparator

Patients receive treatment from the SAM Ultrasonic Diathermy Device 2 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

干预措施: Sustained Acoustic Medicine (Device)

结局指标

主要结局

Ultrasound Diathermy (Degrees Centigrade)

时间窗: 0 - 4 hours

Temperature Measurement On Body (Degrees Centigrade)

次要结局

未报告次要终点

研究者

发起方
ZetrOZ, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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