The Use of a Novel Vaginal Speculum for Endometrial Biopsies (NCT07217353) | Clinical Trial Compass
By InvitationNot Applicable
The Use of a Novel Vaginal Speculum for Endometrial Biopsies
United States100 participantsStarted 2026-02-15
Plain-language summary
The objective of this clinical trial is to determine if a newly-designed and FDA-cleared vaginal speculum (the Bouquet Speculum) will provide better visualization of the cervical os, be easier and more efficient to use, provide more consistent outcomes and decrease the discomfort associated with endometrial biopsy procedures.
Who can participate
Age range
18 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biological women with a uterus, age 18-90
* Previous endometrial biopsy procedure performed at the Minnesota Oncology Clinic
Exclusion Criteria:
* Pregnant women, active pelvic infection, or uncontrolled bleeding dyscrasias as determined by the provider at Minnesota Oncology Clinics
* Biological women without a uterus who are less than 18 years old or greater than 90 years old, or who have not had a previous endometrial biopsy at the Minnesota Oncology Clinic.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a brand-new vaginal speculum for endometrial biopsies — how does using a novel, not-yet-widely-adopted device compare to the standard speculum my biopsy would normally be done with, and does it change anything about the procedure itself?
2Since this trial is enrolling by invitation only, what would make someone eligible to be invited, and is this something my care team would even consider for my situation?
3The study is measuring things like how well the provider can see the cervix and how easy the device is to use — does that mean the focus is more on the doctor's experience than on my comfort or outcomes, and will my biopsy results be just as reliable?
4Because this is listed as phase 'not applicable,' what does that tell us about how much is already known about this device's safety and accuracy, and are there any additional risks I should be aware of compared to a standard biopsy?
5Would it make more sense for me to have my endometrial biopsy done with the standard equipment first, and then consider a study like this later, or does my doctor think participation here wouldn't affect my diagnostic or treatment timeline?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Provider visualization of the cervix, ease of use, and accuracy of a new vaginal speculum being used for endometrial biopsies
Timeframe: Through study completion, an average of 1 year