The Femscope Calm Collect Device

University of Michigan

Status: Completed

Conditions: Cervical Cancer

Treatments: Device: Femscope Calm Collect Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06861504

HUM00224241

Details and patient eligibility

About

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.

Full 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

Enrollment: 13 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Cervical cell collection of traditional brush and Femscope Calm Collect Device

Experimental group

Description:

Cervical cells of the Femscope Calm Collect Device will be evaluated by a board-certified pathologist to determine if the quality and quantity of cells are equivalent to the traditional brush collection.

Treatment:

Device: Femscope Calm Collect Device