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临床试验/NCT00374114
NCT00374114已完成不适用

A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

University of Tennessee4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
Adequate treatment of cervical dysplasia

研究概览

简要总结

Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical dysplasia without compromising the integrity of the cervix in reproductive age women.

详细描述

Women age 18 to 55 years of age with Cervical Intraepithelial Neoplasia 2 or 3 on colposcopy with a negative EndoCervical Curettage are enrolled in a pilot study comparing ultrasonic surgical aspiration and traditional cervical excision procedure for the treatment of cervical dysplasia. In this pilot study, the patients serve as their own control group. Prior to receiving the traditional treatment for cervical dysplasia consisting of Cold Knife Conization with EndoCervical Curettage, each patient's cervix is treated with ultrasonic surgical aspiration. The aspirate is sent to pathology and the results compared with the findings from the cervical cone biopsy. The patients then are followed with Liquid-based Cytology pap smears every 4 to 6 months until completion of the study enrollment/treatment period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • cervical intraepithelial neoplasia II or III
  • negative endocervical curettage
  • not pregnant
  • cervical conization is part of treatment plan

排除标准

  • positive endocervical curettage
  • medically unable to undergo surgery

结局指标

主要结局

Adequate treatment of cervical dysplasia

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (4)

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