Safety and Acceptability Study of Non-Surgical Male Circumcision Device for Adult Male Population When Removing the Foreskin Shortly After Placement of Device Performed at Lusaka and Livingstone, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of incidents related to the change in procedure
研究概览
简要总结
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.
详细描述
To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.
Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex.
Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.
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
- 13 Years 至 49 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages - 13 to 49 years
- •Uncircumcised
- •Participant wants to be circumcised
- •Participant assent to the procedure
- •Legal guardian consent to the procedure for ages 13-18 years
- •Able to understand the study procedures and requirements
- •Agrees to abstain from sexual intercourse for 8 weeks after circumcision
- •Agrees to abstain from masturbation for at least 2 weeks after Removal
- •Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
- •Participant able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
排除标准
- •Legal guardian withholds consent for ages 13-18 years
- •Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
- •Participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- •Known bleeding / coagulation abnormality, uncontrolled diabetes
- •Participant that to the opinion of the investigator is not a good candidate
- •Diabetes Mellitus
- •HIV Sero-positive
研究组 & 干预措施
PrePex Day 0 foreskin removal
Day 0 foreskin removal
干预措施: PrePex (Device)
结局指标
主要结局
Number of incidents related to the change in procedure
时间窗: 8 weeks
To assess the safety of PrePex device when removing the foreskin shortly after device placement by means of the following parameter: Incidence of Serious Adverse Events, when performed by clinicians and nurses
Acceptability of the changes procedure to patients
时间窗: 8 weeks
To asses the new procedure acceptability for patients using the following measures - Evaluation of pain during foreskin removal * Patients willingness to wait for foreskin removal * Odour while device is in situ * Pain at key time points on Removal visit * Discomfort of any type to patients.
次要结局
- Effect of the change in procedure on circumcision healing time(8 weeks)
研究者
David Linyama
General surgeon
Ministry of Health, Zambia