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NCT06861504Completed

The Femscope Calm Collect Device

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
13 (actual)
First submitted
10 Jan 2025
Start date
12 Dec 2024
Primary completion date
28 Aug 2025
Lead sponsor
University of Michigan
NCT number
NCT06861504

What you commit to

  • Study type: Interventional
  • Participants enrolled: 13
  • From 12 Dec 2024 to the primary completion date, 28 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of reproductive cancer

Age

  • Age less than 21 years
  • Age of 46+ years

Other

  • Pregnancy
  • Menopausal
  • Hysterectomy

Who the study is looking for

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

Age in the registry: 21 years to 45 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Michigan Flint
Coordinator of this site? Confirm its status
FlintUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.