The Use of a Novel Vaginal Speculum for Endometrial Biopsies

June 17, 2026 updated by: Rocky Vista University, LLC
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Rocky Vista Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endometrial biopsies with a new vaginal speculum
The use of a novel, FDA-cleared vaginal speculum for endometrial biopsies
Device: Bouquet Speculum
Novel Bouquet Speculum used for endometrial biopsies

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rocky Vista University, LLC

Investigators

  • Study Director: Laura Dement, MA, Rocky Vista University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

October 3, 2025

First Submitted That Met QC Criteria

October 13, 2025

First Posted (Actual)

October 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

October 2025-October 2026

IPD Sharing Access Criteria

Statistical analysis will be performed at RVU through Dr. Mark Payton. Any data that is shared will require a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Study Protocol
    Information identifier: IRB 2025-158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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