Femscope Calm Collect Device for Cervical Cancer

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether the Femscope Calm Collect Device can collect cervical cells as effectively as the traditional brush method used in cervical cancer screening. The device aims to make cervical exams less painful and more comfortable, potentially encouraging more women to undergo regular screenings. The trial includes healthy women aged 21 to 45 who have female reproductive organs and have not experienced reproductive cancer or undergone a hysterectomy. Participants will undergo two vaginal exams and report their comfort levels with each method. As an unphased trial, this study allows participants to contribute to advancements in cervical screening technology, potentially enhancing comfort for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Femscope Calm Collect Device is safe for cervical cell collection?

Research has shown that the Femscope Calm Collect Device is designed to make cervical cancer screening more comfortable. This device aims to replace the traditional speculum and swab method, which many women find uncomfortable.

While specific studies on the safety of the Femscope Calm Collect Device are not available, it is important to note that this trial does not involve any drugs or chemicals. Instead, it focuses on using a new tool to collect cervical cells. The emphasis is on comfort and the patient's experience, rather than on side effects or negative reactions.

As this trial is not primarily about safety, it is reasonable to expect that the device will be well-tolerated. The main goal is to determine if it collects cells as effectively as the traditional method while also reducing discomfort during the procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Femscope Calm Collect Device because it offers a new method for collecting cervical cells. Unlike traditional methods that use a brush, this device aims to provide a more comfortable and potentially less invasive experience for patients. The key interest lies in whether it can deliver cell samples of similar quality and quantity to the existing standard, which could make cervical cancer screenings more accessible and less stressful. This innovation could lead to wider acceptance and more frequent participation in important cervical cancer screening programs.

What evidence suggests that the Femscope Calm Collect Device is effective for cervical cancer screening?

Research has shown that the Femscope Calm Collect Device is designed to reduce pain and discomfort during cervical cancer screening. In this trial, participants will have cervical cells collected using both the traditional brush and the Femscope Calm Collect Device. Studies have found that devices simplifying the screening process can enhance test effectiveness and reduce patient discomfort. The Femscope device replaces traditional screening tools, aiming to make the procedure more comfortable. By potentially reducing pain, this device could encourage more women to undergo regular screenings, leading to better early detection and treatment of cervical cancer. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06861504/the-femscope-calm-collect-device

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 ...

2. globalhealthequity.umich.edu globalhealthequity.umich.edu/news-events/news/u-m-flint-womens-health-team-wins-competition-innovative-femscope

U-M Flint Women's Health Team Wins Competition with ... The Femscope Calm Collect system is a slim, cell-collection device with a scope that would replace the speculum and swab typically used.

3. withpower.com withpower.com/trial/phase-uterine-cervical-neoplasms-11-2024-aa8ff

Femscope Calm Collect Device for Cervical Cancer 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10676510/

A Comprehensive Review of Cervical Cancer Screening ... The reviewed devices either simplified the screening procedure to improve the clinical efficiency and accuracy in screening, reduced the pain and discomfort ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/condition/30/cervical-cancer?activelyRecruiting=false&page=47

Cervical Cancer Clinical Research Trials The Femscope Calm Collect Device. The FemScope Calm Collect Device is a novel medical device intended for vaginal inspection, cervical cancer screening ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190028S009B.pdf

Summary of Safety and Effectiveness Data (SSED) This test detects the high-risk HPV types 16,. 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in the specimens listed below. Clinician-collected ...