An interventional study of Femscope Calm Collect Device in Cervical Cancer, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-27.
Sponsored by University of Michigan · Not applicable, Interventional, and Device feasibility
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:
Participants will
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
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 13 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
- Healthy female ages 21-45 with female reproductive organs present at the time of study.
Exclusion Criteria:
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.
Device: Femscope Calm Collect Device
The Femscope Calm Collect Device uses a patented brush for cervical cell collection.
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.
Time frame: 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.
Time frame: 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
Time frame: Immediately post-procedure
Plan to share: Yes — Will need to determine if Femscope Calm Collect Device meets cervical cell collection criteria.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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