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临床试验/NCT02890277
NCT02890277Unknown不适用

Treatment of Nonneoplastic Epithelial Disorders of Skin and Mucosa of Vulva With High Intensity Focused Ultrasound

Jinan Military General Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Grading changes of nonneoplastic epithelial disorders from colposcopy and biopsy pathology

研究概览

简要总结

Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic diseases shown as female genital skin and mucosal tissue degeneration and pigmentation change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug or surgical treatments. However, the effect is not good enough, but the diseases often recur and severely affect patients' quality of life. In this study, the investigators combined the technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to treat. The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect. At the meantime, the standardized treatment procedure, methods and efficacy criterion were all stipulated to achieve satisfactory results, which could be used to clinical treatments. So far, the investigators have not seen similar study reported internationally.

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 78 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Treatment group

Experimental

干预措施: the high intensity focused ultrasound (Mianyang Sonic electronic LLC) (Device)

Treatment group

Experimental

干预措施: Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel). (Drug)

结局指标

主要结局

Grading changes of nonneoplastic epithelial disorders from colposcopy and biopsy pathology

时间窗: One month before treatment and 2,4,6 weeks and 2,6,12,24 monthes after treatment

The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect.

次要结局

未报告次要终点

研究者

发起方
Jinan Military General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Geping Yin

Professor/Surgeon,Leader of Department of Gynecology

Jinan Military General Hospital

研究点 (1)

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