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ENROLLING BY INVITATION
NCT06496295

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

Sponsor: Rocky Vista University, LLC

View on ClinicalTrials.gov

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

Interventions

DEVICE

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