Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
研究概览
简要总结
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.
详细描述
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. To evaluate safety, the investigators will clinically observe for adverse events during the course of healing. The investigators will also evaluate to length of time taken for complete healing to be achieved.
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
- 1 Month 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Must be accompanied by the parent or legally acceptable representative (LAR), who freely consents for participation of the child into the study;
- •Assent from participant 7 years of age and above who understand study procedure;
- •Aged between 1 month and 17 years(inclusive);
- •Body weight of more than 2.5 kgs and penile shaft more than 1 cm in length.
- •Must be in good general health;
- •Must be free of genital ulcerations or other visible signs of STI (on examination);
- •Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
- •Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
- •Parent or LAR must have a cell phone or access to a cell phone; and,
- •Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.
排除标准
- •Has a known allergy or sensitivity to lidocaine or other local anesthesia;
- •Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- •Has known bleeding/clotting disorder (e.g. hemophilia);
- •Has any congenital genitourinary abnormality;
- •Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or
- •Is currently participating in another biomedical research study.
结局指标
主要结局
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
时间窗: 42 days after circumcision
Documentation of adverse events based on clinical exam findings
次要结局
- To determine the acceptability of the Shang Ring device by the participants (or their parents)(42 days after circumcison)
- To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.(42 days after circumcision)
- To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.(42 days after circumcision)
- To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents(42 days after circumcision)