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

Enrolling by invitation

Conditions studied: Cervical Cancer Screening

In brief

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 facts

Study ID

NCT06496295

Run by

Rocky Vista University, LLC

People needed

200

Starts

2024-11-14

Expected to finish

2025-12-30

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• women, gender diverse patients with an intact cervix
• women ages 18-25
• Exclusion Criteria: no prior vaginal speculum exam
• under age 18 or over age 65
• lack of a uterine cervix
• no prior vaginal speculum exam

Where it is running

• Rocky Vista University — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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