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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.
To answer the question, "How does the Bouquet speculum compare to a two-bladed speculum in terms of patient comfort, provider visualization, ease of use, and accuracy for obtaining samples for in-office endometrial biopsies for patients with endometrial cancer requiring follow up procedures?" the investigators will have an observational study of 100 women aged 18-90 years old that have previously had an endometrial biopsy with the use of a two-bladed speculum. Providers (physicians, physician's assistants, and nurse practitioners) at Minnesota Oncology Clinics will be educated on how to use the Bouquet speculum via a Zoom training session, a video presentation, and step-by-step instructional page that has been used in previous studies on the product. The providers will use the Bouquet speculum for endometrial biopsies on patients that consent to the study that come into the clinic for the procedure. The providers will do the procedures in the same way as they usually do but will use the Bouquet speculum instead of a two-bladed speculum.
To analyze the question, this research will measure the variables of patient comfort level, and provider ease-of-use with the Bouquet speculum, the extent of visualization of the cervix, and accuracy of sampling of the endometrium lining (the necessary result of an endometrial biopsy). The variables of patient weight and parity will be included in the patient survey to determine if they have an effect on the outcomes of visualization, ease-of-use, accuracy of sampling, and patient comfort level.These measurements will be recorded via a survey for the patient and provider following the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometrial biopsies with a new vaginal speculum | Experimental | The use of a novel, FDA-cleared vaginal speculum for endometrial biopsies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bouquet Speculum | Device | Novel Bouquet Speculum used for endometrial biopsies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Provider visualization of the cervix, ease of use, and accuracy of a new vaginal speculum being used for endometrial biopsies | A simple survey is filled out by the provider regarding whether the visualization of the cervix was better, the same, or worse with the new vaginal speculum. Similarly, the provider will be asked on the survey about the ease of use (easier, same more difficult). The last criteria will be de-identified data from the cohort to see if an adequate sample was obtained of the endometrium. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Biological females with an intact uterus who may identify as male
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| Name | Affiliation | Role |
|---|---|---|
| Laura Dement, MA | Rocky Vista University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Vista Health Clinic | Englewood | Colorado | 80112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40011116 | Result | Luzarraga Aznar A, Canton R, Loren G, Carvajal J, de la Calle I, Masferrer-Ferragutcasas C, Serra F, Bebia V, Bonaldo G, Angeles MA, Cabrera S, Palomar N, Vilarmau C, Marti M, Rigau M, Colas E, Gil-Moreno A. Current challenges and emerging tools in endometrial cancer diagnosis. Int J Gynecol Cancer. 2025 Apr;35(4):100056. doi: 10.1016/j.ijgc.2024.100056. Epub 2024 Dec 18. | |
| 16084259 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| IRB 2025-158 | Study Protocol | View IPD |
All IPD that underlie results in a publication
October 2025-October 2026
Statistical analysis will be performed at RVU through Dr. Mark Payton. Any data that is shared will require a data sharing agreement.
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Result |
| Amant F, Moerman P, Neven P, Timmerman D, Van Limbergen E, Vergote I. Endometrial cancer. Lancet. 2005 Aug 6-12;366(9484):491-505. doi: 10.1016/S0140-6736(05)67063-8. |
| 40599808 | Result | Khan S, Waters-Kellar L, Barsh E, Shannon A, Clark S, Ryznar RJ, Trawick A, Payton M, Bouquet J. A Survey of Physicians and Patients in Pakistan Assessing the Improvement of Visualization of the Cervix, Ease of Use, and Patient Comfort Using a Newly Designed Vaginal Speculum: A Pilot Study. Med Devices (Auckl). 2025 Jun 11;18:309-317. doi: 10.2147/MDER.S509134. eCollection 2025. |
| 40308928 | Result | Bouquet JM, Morris E, Zapata I. A novel and cost-effective model to screen and treat cervical cancer and precancers at the point of care. Front Public Health. 2025 Apr 16;13:1527172. doi: 10.3389/fpubh.2025.1527172. eCollection 2025. |
| 37790696 | Result | Bouquet JM, Naji R, Armas CA, Roldan V, Selkhi S, Bentley CZ, Zapata I, Fisher J. An Innovative Design for the Vaginal Speculum. Med Devices (Auckl). 2023 Sep 25;16:211-218. doi: 10.2147/MDER.S415558. eCollection 2023. |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |