The Femscope Calm Collect Device

Last updated: October 23, 2025
Sponsor: University of Michigan
Overall Status: Completed

Phase

N/A

Condition

Cervical Cancer

Dysfunctional Uterine Bleeding

Vaginal Cancer

Treatment

Femscope Calm Collect Device

Clinical Study ID

NCT06861504
HUM00224241
  • Ages 21-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Menopausal

  • Age less than 21 years

  • Age of 46+ years

  • History of reproductive cancer

  • Hysterectomy

Study Design

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: Femscope Calm Collect Device
Phase:
Study Start date:
December 12, 2024
Estimated Completion Date:
August 28, 2025

Study Description

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

Connect with a study center

  • University of Michigan and MyMichigan Health

    Flint, Michigan 48502
    United States

    Site Not Available

  • University of Michigan Flint

    Flint 4992982, Michigan 5001836 48502
    United States

    Site Not Available

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