The Femscope Calm Collect Device
Completed · Not applicable
Conditions studied: Cervical Cancer
In brief
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.
Key facts
- Study ID
- NCT06861504
- Run by
- University of Michigan
- People needed
- 13
- Starts
- 2024-12-12
- Expected to finish
- 2025-08-28
- Last updated by the study team
- 2025-10-27
Who can join
Age: 21 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Healthy female ages 21-45 with female reproductive organs present at the time of study.
You may not qualify if…
- Pregnancy
- Menopausal
- Age less than 21 years
- Age of 46+ years
- History of reproductive cancer
- Hysterectomy
Where it is running
- University of Michigan Flint — Flint, Michigan, United States
Full record on ClinicalTrials.gov
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