Cervical CancerNCT06861504
The Femscope Calm Collect Device
A study testing Femscope Calm Collect Device in people with Cervical Cancer, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Femscope Calm Collect Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 28 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female ages 21-45 with female reproductive organs present at the time of study.
Who cannot join
- Pregnancy
- Menopausal
- Age less than 21 years
- Age of 46+ years
- History of reproductive cancer
- Hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Femscope Calm Collect Device to Obtain Cervical Cells for Cancer Screening
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:
- Increase the number of women who get screened for cervical cancer.
- Improve patient acceptance of getting cervical screening on a routine basis.
- Decrease pain and discomfort for patients having a PAP smear procedure.
Read more
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.
Read the 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
- Conditions
- Cervical Cancer
- Being tested
- Femscope Calm Collect Device
- Keywords
- Cervical cancer screening
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femscope Calm Collect DeviceDevice
The Femscope Calm Collect Device uses a patented brush for cervical cell collection.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cell collection of traditional brush and Femscope Calm Collect Device | Experimental | 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. Receives: Device: Femscope Calm Collect Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method
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.
Measured: 1 hour
Number of Participants Who Experienced Pain/Discomfort During The Femscope Calm Collect Procedure
A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the Femscope Calm Collect Procedure.
Measured: Immediately post-procedure
Number of Participants Who Experienced Pain/Discomfort During The Regular Pap Procedure
A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the regular Pap procedure
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start12 Dec 2024
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Femscope Calm Collect Device will be used to collect a sample of cervical cells that a board-certified pathologist will read.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn S Filter, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861504
- Sponsor's protocol ID
- HUM00224241
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2025
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will need to determine if Femscope Calm Collect Device meets cervical cell collection criteria.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Femscope Calm Collect Device to Obtain Cervical Cells for Cancer Screening
- ClinicalTrials.gov ID
- NCT06861504
- Acronym / sponsor ID
- HUM00224241
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Increase the number of women who get screened for cervical cancer.
- Improve patient acceptance of getting cervical screening on a routine basis.
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Femscope Calm Collect Device will be used to collect a sample of cervical cells that a board-certified pathologist will read.
| Arm | Type | Receives |
|---|---|---|
| Cervical cell collection of traditional brush and Femscope Calm Collect Device | Experimental | Device: Femscope Calm Collect DeviceCervical 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 may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy female ages 21-45 with female reproductive organs present at the time of study.
Key exclusion criteria (6 listed)
- Pregnancy
- Menopausal
- Age less than 21 years
- Age of 46+ years
- History of reproductive cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femscope Calm Collect DeviceThe Femscope Calm Collect Device uses a patented brush for cervical cell collection. | Device | Cervical cell collection of traditional brush and Femscope Calm Collect Device |
Primary outcome
Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method
Time frame: 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
Time frame: 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
Time frame: Immediately post-procedure
A binary (yes/no) assessment of whether the participant experienced pain or discomfort during the regular Pap procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: Yes. Will need to determine if Femscope Calm Collect Device meets cervical cell collection criteria.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femscope Calm Collect Device in people with Cervical Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specimen Adequacy Using The Femscope Calm Collect Device vs. The Traditional Brush Method (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.