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

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Rocky Vista University, LLC
Study ID
NCT06496295
Status
Enrolling By Invitation

Conditions

  • Cervical Cancer Screening

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Vaginal Speculum Exam — DEVICE
    Evaluating the visibility of the cervix, ease-of-use, and comfort of a new vaginal speculum.

Study Details

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.

Key Dates

Start date
Nov 14, 2024
Status verified
Sep 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Vista UniversityEnglewoodColorado80112-

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By research site
Rocky Vista University· Englewood, CO

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