跳至主要内容
临床试验/NCT06861504
NCT06861504已完成不适用

The Femscope Calm Collect Device to Obtain Cervical Cells for Cancer Screening

University of Michigan2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method

研究概览

简要总结

The goal of this clinical trial is to determine if cervical cells collected by the Femscope Calm Collect Device in women (sex assigned at birth) of adult age are the same quality and quantity as the cervical cells collected by the traditional brush method for cervical cancer screening. The main questions it aims to answer are:

  1. Increase the number of women who get screened for cervical cancer.
  2. Improve patient acceptance of getting cervical screening on a routine basis.
  3. Decrease pain and discomfort for patients having a PAP smear procedure.

Participants will

  • Have two vaginal exams to collect cervical cells.
  • State decreased pain and discomfort for patients having a PAP smear procedure.
  • The Femscope Calm Collect Device (FCCD) will be more comfortable for the patient as measured by a patient satisfaction survey comparing the FCCD and the traditional speculum method of obtaining cervical cells.

详细描述

The FemScope Calm Collect Device is a novel medical device intended for vaginal inspection, cervical cancer screening, rectal cancer screening, and discharge/cell retrieval. The device allows for increased comfort (emotionally and physically) to the patient while meeting the requirements of a genital exam.

The FemScope system includes a light and camera, enabling visualization of the vagina and cervix and display on a screen. It also provides brushing/retrieval means, allowing the provider to obtain necessary cervical cells for a pap smear, HPV, and specimens needed for sexually transmitted disease (STI) testing. The system will also allow the direct visualization of rectal tissue sampled for human papillomavirus/rectal cancer. The system is designed to replace the speculum, provide the tools needed to perform comprehensive pelvic and topical rectal exams, provide cervical cancer screens, and be cost-competitive with existing speculum and tissue swab systems. It is simple and easy to use. The device comprises a reusable base portion, a removable protective sleeve, and a single-use cell retrieval cap for improved cost-effectiveness.

This instrument will revolutionize women's health care, replacing the antiquated speculum examination with modern scopes like those used to visualize many other portions of the human body. Having the instrument designed to facilitate exams in the LGBTQIA community is sorely needed and will improve gynecologic and genital examinations in that community

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

盲法说明

All specimens collected will receive a randomized number so the pathologist is not aware of the samples collected by the traditional brush method (Pap smear) and the cells collected by the Femscope Calm Collect Device.

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - Healthy female ages 21-45 with female reproductive organs present at the time of study.

排除标准

  • Pregnancy
  • Menopausal
  • Age less than 21 years
  • Age of 46+ years
  • History of reproductive cancer
  • Hysterectomy

结局指标

主要结局

Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method

时间窗: 1 hour

Specimen adequacy will be assessed using the Bethesda System For Reporting Cervical Cytology. Specimens will be rated as Satisfactory or Unsatisfactory for evaluation. The presence/absence of a Endocervical/Transformation Zone (EC/TZ) component, partially obscuring blood, and inflammation are indicators the Pap test is satisfactory for evaluation.

Number of Participants Who Experienced Pain/Discomfort During The Femscope Calm Collect Procedure

时间窗: Immediately post-procedure

A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the Femscope Calm Collect Procedure.

Number of Participants Who Experienced Pain/Discomfort During The Regular Pap Procedure

时间窗: Immediately post-procedure

A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the regular Pap procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marilyn S Filter

Professor of Nursing, School of Nursing, The University of Michigan-Flint

University of Michigan

研究点 (2)

Loading locations...

相似试验

The Femscope Calm Collect Device | 临床试验