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

NCT06496295 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Cervical Cancer Screening

Interventions

DEVICE

Vaginal Speculum Exam

Evaluating the visibility of the cervix, ease-of-use, and comfort of a new vaginal speculum.

Sponsors & Collaborators

  • Rocky Vista University, LLC

    lead OTHER

Principal Investigators

  • Jean Bouquet, DO · Rocky Vista University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06496295 on ClinicalTrials.gov