Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2024-12-12
2025-08-28
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Cervical cell collection of traditional brush and Femscope Calm Collect Device
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.
Femscope Calm Collect Device
The Femscope Calm Collect Device uses a patented brush for cervical cell collection.
Interventions
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Femscope Calm Collect Device
The Femscope Calm Collect Device uses a patented brush for cervical cell collection.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Menopausal
* Age less than 21 years
* Age of 46+ years
* History of reproductive cancer
* Hysterectomy
21 Years
45 Years
FEMALE
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Marilyn S Filter
Professor of Nursing, School of Nursing, The University of Michigan-Flint
Locations
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University of Michigan Flint
Flint, Michigan, United States
Countries
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Other Identifiers
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HUM00224241
Identifier Type: -
Identifier Source: org_study_id
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