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OpenTrials
Completed

NCT Number: NCT06861504

The Femscope Calm Collect Device

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Flint

Flint, Michigan, 48502, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Femscope Calm Collect Device

Device

The Femscope Calm Collect Device uses a patented brush for cervical cell collection.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: Immediately post-procedure

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

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

    Time frame: Immediately post-procedure

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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