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NCT06496295Enrolling by invitation

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

Evaluating the Efficacy and Use of the Bouquet Speculum for Cervical Cancer Screening in a Diverse Population of Patients

Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
200 (estimated)
First submitted
3 Jul 2024
Start date
14 Nov 2024
Primary completion date
30 Dec 2025
Lead sponsor
Rocky Vista University, LLC
NCT number
NCT06496295

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 14 Nov 2024 to the primary completion date, 30 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • no prior vaginal speculum exam

Age

  • under age 18 or over age 65

Other

  • lack of a uterine cervix

Who the study is looking for

  • women, gender diverse patients with an intact cervix
  • women ages 18-25

Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rocky Vista University
Coordinator of this site? Confirm its status
EnglewoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.