Not Yet RecruitingNot Applicable

The Use of a Novel Vaginal Speculum for Endometrial Biopsies

100 participantsStarted 2025-10-15

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 range18 Years – 90 Years

SexFEMALE

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.

What they're measuring

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

Trial details

NCT IDNCT07217353

SponsorRocky Vista University, LLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

Contact for this trial

Jean M Bouquet, DO

303-868-3675 jbouquet@rvu.edu

View on ClinicalTrials.gov More Endometrial Cancer trials