Clinical trial NCT06861504: The Femscope Calm Collect Device
Official title: The Femscope Calm Collect Device to Obtain Cervical Cells for Cancer Screening
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer screening
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Femscope Calm Collect Device will be used to collect a sample of cervical cells that a board-certified pathologist will read.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method
timeFrame: 1 hour
measure: Number of Participants Who Experienced Pain/Discomfort During The Femscope Calm Collect Procedure
timeFrame: Immediately post-procedure
measure: Number of Participants Who Experienced Pain/Discomfort During The Regular Pap Procedure
timeFrame: Immediately post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: University of Michigan and MyMichigan Health
state: Michigan
Study officials:
References: