University of Michigan
Marilyn S Filter
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.
Cervical Cancer
Femscope Calm Collect Device
NA
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
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 10 participants |
| Masking : | NONE |
| Masking Description : | 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. |
| Primary Purpose : | DEVICE_FEASIBILITY |
| Official Title : | The Femscope Calm Collect Device to Obtain Cervical Cells for Cancer Screening |
| Actual Study Start Date : | 2024-12-12 |
| Estimated Primary Completion Date : | 2025-03 |
| Estimated Study Completion Date : | 2025-03 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 21 Years to 45 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Michigan and MyMichigan Health
Flint, Road cancer, United States, 48502