Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
Record status
This record was last updated September 25, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-10; most recent amendment 2025-09-24.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-12-10
Trial Details
NCT Number NCT06496295
Lead Sponsor Rocky Vista University, LLC
Conditions Cervical Cancer Screening
Enrollment 200 participants
Start Date 2024-11-14
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-25