NCT07217353

The Use of a Novel Vaginal Speculum for Endometrial Biopsies

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Rocky Vista University, LLC · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DEVICE	Bouquet Speculum	Novel Bouquet Speculum used for endometrial biopsies

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-03-31
• Completion: 2026-06-15
• First posted: 2025-10-15
• Last updated: 2025-10-15

Regulatory

• FDA-regulated device study