The Use of a Novel Vaginal Speculum for Endometrial Biopsies

NCT07217353 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-158
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Cancer

Keywords

Endometrial biopsies; Endometrial Cancer; Vaginal Speculum

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Endometrial biopsies with a new vaginal speculum

EXPERIMENTAL

The use of a novel, FDA-cleared vaginal speculum for endometrial biopsies

Device: Bouquet Speculum

Interventions

Bouquet Speculum DEVICE

Novel Bouquet Speculum used for endometrial biopsies

Endometrial biopsies with a new vaginal speculum

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Biological females with an intact uterus who may identify as male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological women with a uterus, age 18-90
• Previous endometrial biopsy procedure performed at the Minnesota Oncology Clinic

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rocky Vista University, LLC: lead

Related Publications (5)

• 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.

  PMID: 40011116 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.

  PMID: 16084259 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.

  PMID: 40599808 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.

  PMID: 40308928 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.

  PMID: 37790696 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Laura Dement, MA

  Rocky Vista University

  STUDY DIRECTOR

Central Study Contacts

Jean M Bouquet, DO

CONTACT

303-868-3675; jbouquet@rvu.edu

Mark Payton, PhD

CONTACT

(720) 795-9735; mpayton@rvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 15, 2025
• Study Start: October 15, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: October 2025-October 2026
• Access Criteria: Statistical analysis will be performed at RVU through Dr. Mark Payton. Any data that is shared will require a data sharing agreement.