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

NCT06496295 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: IRB #2023-266
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer Screening

Keywords

Vaginal Speculum; Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Evaluating the use of the Bouquet Speculum for cervical visibility, ease-of-use, and comfort level

  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

Interventions

Vaginal Speculum Exam DEVICE

Evaluating the visibility of the cervix, ease-of-use, and comfort of a new vaginal speculum.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women, gender diverse patients with an intact cervix
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rocky Vista University, LLC: lead

Study Sites (1)

Rocky Vista University

Englewood, Colorado, 80112, United States

Location

Related Publications (1)

• 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 BACKGROUND

Related Links

• Publication in the Journal of Women's Health

Study Officials

• Jean Bouquet, DO

  Rocky Vista University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: November 14, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)