The Use of a Novel Vaginal Speculum for Cervical Cancer Screening in Sunrise Community Health Patients

September 24, 2025 updated by: Rocky Vista University, LLC

Evaluating the Efficacy and Use of the Bouquet Speculum for Cervical Cancer Screening in a Diverse Population of Patients

The specific aim of this research is to determine if the Bouquet Speculum TM , compared to the existing 2-bladed vaginal speculum, provides better visualization of the cervix, is easier for the provider to use and is more comfortable for the patient.

Additionally, the clinician's experience with vaginal speculum exams and the patient's last vaginal speculum exam, parity and self-reported weight classification will be surveyed to see what effect, if any, it has on visualization of the cervix, ease-of use, and comfort level for the patient.

The objective of this project is to investigate the use of a novel, FDA-cleared, 5-petaled vaginal speculum in cervical cancer screening (Pap test and/or HPV probe) on 200 patients from Sunrise Community Health Clinics in the Denver-Metro area.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The Bouquet Speculum TM will be used by a variety of clinicians at Sunrise Clinics including physicians, PAs, and NPs for routine cervical cancer screening including Pap tests and/or HPV probes. 200 women will be selected from the Sunrise Clinics in the Denver-Metro area. Women who do not have a cervix or have never had a vaginal speculum exam will be excluded. The inclusion criteria is women ages 18-65.

The clinician will be provided with a one-page Instructions for Use document and a 2-minute instructional video on how to use the Bouquet Speculum TM. The clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1. visualization of the cervix 2. ease-of-use 3. experience with speculum exams. The patient will be consented and de-identified and assigned a number to their survey of four questions: 1. comfort level 2. last vaginal speculum exam 3. self-reported description of weight (underweight, normal, overweight, obese) 4. parity (number of births).

The length of the study is anticipated to be three months. The surveys will be collected and tabulated and then evaluated by Dr. Mark Payton who has experience with the Pakistan study.

The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans.

Proprietary Name: Bouquet Vaginal Speculum Classification Name: RETRACTOR, VAGINAL Product Code: HDL Device Class:2 Regulation Number: 884.4520 Medical Specialty: Obstetrics/Gynecology Registered Establishment Name: Viospex Registered Establishment Number:3012447313 Owner/Operator: Viospex Owner/Operator Number:10051911 Establishment Operations: Manufacture

Study Type

Observational

Enrollment (Estimated)

200

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 University

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

Yes

Sampling Method

Probability Sample

Study Population

Sunrise Community Health Clinics provide affordable health care to the uninsured and underinsured. This particular study involves women or gender diverse patients with a cervix and who have had a previous vaginal speculum exam.

Description

Inclusion Criteria:

  • women, gender diverse patients with an intact cervix
  • women ages 18-25

Exclusion Criteria: no prior vaginal speculum exam

  • under age 18 or over age 65
  • lack of a uterine cervix
  • no prior vaginal speculum exam

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the use of the Bouquet Speculum for cervical visibility, ease-of-use, and comfort level
Time Frame: 3 months

200 women will be selected from the Sunrise Clinics in the Denver-Metro area. The clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1. visualization of the cervix 2. ease-of-use 3. experience with speculum exams. The patient will be consented and de-identified and assigned a number to their survey of four questions: 1. comfort level 2. last vaginal speculum exam 3. self-reported description of weight (underweight, normal, overweight, obese) 4. parity (number of births).

The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans. Regulation Number: 884.4520
3 months

Collaborators and Investigators

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

Sponsor

Rocky Vista University, LLC

Investigators

  • Principal Investigator: Jean Bouquet, DO, 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

Helpful Links

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)

November 14, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #2023-266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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