Performance Proof of The Norma-Sense Gen 3 - Wearing Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- color status of the NORMA-SENSE gen 3 and the pH measurement.
研究概览
简要总结
This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level
详细描述
This study was designed to validate the color appearance on the NORMA-SENSE gen 3. The NORMA-SENSE gen 3 changes color when worn by the user and comes into contact with vaginal secretions having an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE gen 3 and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE gen 3 results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, age 18 years or greater with or without symptoms of vaginal infection.
- •Subject is ready to sign the informed consent form.
排除标准
- •Subject is unable or unwilling to cooperate with study procedures.
- •Subject is currently participating in another clinical study.
- •Subject suffers from vaginal bleeding or is menstruating.
- •Subject that have had sexual relations within the last 12 hours.
- •Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
- •Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.
研究组 & 干预措施
color status
The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test.
干预措施: NORMA-SENSE (Device)
结局指标
主要结局
color status of the NORMA-SENSE gen 3 and the pH measurement.
时间窗: 3 days
agreement between the color status of the NORMA-SENSE gen 3 as reported by the subject after using the panty liners, and the pH measurement with Nitrazine paper.
次要结局
- physical comfort in using NORMA-SENSE gen 3 and the result reading clarity(3 days)