ISRCTN66112760已完成不适用
An open, prospective, comparative clinical trial to evaluate the improvement of the colposcopist with the use of DySIS™ compared to conventional colposcopy
VU University Medical Centre (The Netherlands)0 个研究点目标入组 400 人开始时间: 2007年4月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •2. 18 years of age or older
- •3. Intact cervix (no history of Loop Electrosurgical Excision Procedure [LEEP] or surgical treatment involving damage to the transformation zone of the cervix)
- •4. Study group only: an abnormal cytological test result and/or positive high-risk Human Papillomavirus (hrHPV) test
- •5. Control group only: to be able to undergo a colposcopy (according to the gynaecologist)
- •6. Sufficient knowledge of the Dutch or English language
- •7. Able to understand the content of the study (according to the gynaecologist)
- •8. Signed informed consent form
排除标准
- •1. History of surgery on the cervix
- •2. Previous pelvic radiotherapy
- •3. Pregnancy or pregnant in the last three months
- •4. Breast-feeding, or breast-feeding in the last three months
- •5. Heavy bleeding (menstruation or other) or excessive vaginal discharge in which a colposcopy cannot be performed. Enrolment in the study protocol will be postponed until the condition is resolved according to the gynaecologist?s medical judgment
- •6. Self-referring women without an abnormal smear
研究者
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