NCT00572754Unknown2 期
Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision
Progressus1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2007年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The operative and short-term post-operative safety rates
研究概览
简要总结
The objective of this clinical investigation is to provide the first and preliminary clinical data to study the safety and efficacy of male circumcision where the dry circumcision method is employed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects, aged 21 years or above at the point of screening for participation.
- •Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •Subjects who, in the opinion of the clinical investigator, are able to understand this clinical investigation co-operate with the investigational procedures and are willing to return to the clinical centre for all the required post-treatment follow-ups.
- •Subjects willing to be circumcised for cultural reasons.
- •Subjects living in the site's area.
- •Subjects who can be easily contacted by telephone.
- •Subjects who can correctly speak and correctly read English.
排除标准
- •Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
- •Subjects who are circumcised (i.e. subjects with a foreskin unable to cover the entire glans without pulling on the foreskin).
- •Subjects with a disease which is an indication for circumcision: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical study with an investigational product in the last 6 months.
- •Subjects who have an abnormal penile anatomy.
- •Subjects who are currently involved in any injury litigation claims.
- •Subjects who have penile diseases or lesions.
- •Subjects who have clinical symptoms of sexually transmitted infections.
- •Subjects with opportunistic infections.
- •Subjects with known diabetes, known allergy to local anaesthesia or with known abnormal blood coagulation.
- •Subjects whose penile circumference is higher (>3mm) or lower (<3mm) than the available circumcision tubes.
- •Subjects with a thick foreskin (difference between the diameter of covered glans and uncovered glans > 5mm).
结局指标
主要结局
The operative and short-term post-operative safety rates
时间窗: 1 month
次要结局
- Mobibidity and mortality The length of the residual foreskin.(1 month)
研究者
研究点 (1)
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