Femscope Calm Collect Device for Cervical Cancer

Overseen By Marilyn Filter, Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Menopausal, Reproductive cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for healthy women aged 21-45 with female reproductive organs, aiming to see if the Femscope Calm Collect Device can improve cervical cancer screening by being less painful and more acceptable to patients compared to the traditional brush method.

Inclusion Criteria

I am a healthy woman aged 21-45 with all my female reproductive organs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two vaginal exams to collect cervical cells using both the Femscope Calm Collect Device and the traditional brush method

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedure pain or discomfort and specimen adequacy is assessed

1 hour

Treatment Details

Interventions

• Femscope Calm Collect Device

Trial Overview The study tests whether the Femscope Calm Collect Device can collect cervical cells of equal quality and quantity as a traditional brush. It also evaluates patient comfort and willingness to undergo routine screenings using this new device.

Participant Groups

Group I: Cervical cell collection of traditional brush and Femscope Calm Collect Device Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+