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The Use of a Novel Vaginal Speculum for Cervical Cancer Screening in Sunrise Community Health Patients
Sponsor: Rocky Vista University, LLC
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.
Official title: Evaluating the Efficacy and Use of the Bouquet Speculum for Cervical Cancer Screening in a Diverse Population of Patients
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2024-11-14
Completion Date
2025-12-30
Last Updated
2025-09-25
Healthy Volunteers
Yes
Conditions
Interventions
Vaginal Speculum Exam
Evaluating the visibility of the cervix, ease-of-use, and comfort of a new vaginal speculum.
Locations (1)
Rocky Vista University
Englewood, Colorado, United States