The Use of a Novel Vaginal Speculum for Endometrial Biopsies

Not Applicable

Not yet recruiting

• Conditions: Endometrial Cancer

• Registration Number: NCT07217353
• Lead Sponsor: Rocky Vista University, LLC

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-03
• Study First Submitted QC: 2025-10-13
• Last Update Submitted: 2025-10-13
• Study Start: 2025-10-15
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-15
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Provider visualization of the cervix, ease of use, and accuracy of a new vaginal speculum being used for endometrial biopsies	Through study completion, an average of 1 year	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.