A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Assessment of introducer
研究概览
简要总结
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
详细描述
This project is to assess if the introducer, "calla", can be used in place of a speculum during a routine Pap smear. For the patient arm, the introducer will be used in conjunction with standard of care procedures. The healthy volunteer arm will include taking the introducer home for a week to determine if each person can find their cervix without the help of a physician. As well as completing surveys on ease of use and demographics related to their medial history.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female
- •Aged 21-65 years
- •Have had a pelvic exam
- •Have conversational proficiency in English
- •Highest level of education attained
排除标准
- •- Pregnant women
研究组 & 干预措施
Patient surveillance
The introducer will be used during annual Pap smears for cervical cancer screening.
干预措施: Introducer "calla" device (Device)
Healthy Volunteers
There will be 2 types of healthy volunteers recruited to participate in this arm. The home study is to determine ease of use/feasibility of the introducer. The other group of healthy volunteers will be interviewed only. The goal of this study is to better understand how to improve women's health through learning about women's perceptions of their reproductive anatomy, specifically the cervix, comfort in discussing reproductive health topics with providers, and thoughts on two tools used to see the cervix.
干预措施: Interviews only (Behavioral)
结局指标
主要结局
Assessment of introducer
时间窗: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)
We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum
次要结局
未报告次要终点