The Femscope Calm Collect Device

Not Applicable

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06861504
• Lead Sponsor: University of Michigan

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

Study Timeline

• Study Start: 2024-12-12
• Study First Submitted: 2025-01-10
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Primary Completion: 2025-03
• Study Completion: 2025-03
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method	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.
Number of Participants Who Experienced Pain/Discomfort During The Femscope Calm Collect Procedure	Immediately post-procedure	A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the Femscope Calm Collect Procedure.
Number of Participants Who Experienced Pain/Discomfort During The Regular Pap Procedure	Immediately post-procedure	A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the regular Pap procedure

Trial Locations

Locations (1)

University of Michigan and MyMichigan Health; 🇺🇸 Flint, Michigan, United States