NCT06496295

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

Enrolling by Invitation
Not specifiedAges 18–65Observational
Rocky Vista University, LLC
~200 participants
Updated 2025-09-25 on ClinicalTrials.gov
What's tested:Vaginal Speculum Exam

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluating the use of the Bouquet Speculum for cervical visibility, ease-of-use, and comfort level
Measured over 3 months
Cervical Cancer Screening
1 sites across 1 states
Colorado1
  • Jean Bouquet, DO · PRINCIPAL_INVESTIGATOR · Rocky Vista University

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

under age 18 or over age 65
lack of a uterine cervix
no prior vaginal speculum exam
  • Evaluating the use of the Bouquet Speculum for cervical visibility, ease-of-use, and comfort level3 months

    200 women will be selected from the Sunrise Clinics in the Denver-Metro area. The clinician will then be assigned a letter and complete three questions on a survey for each patient regarding 1. visualization of the cervix 2. ease-of-use 3. experience with speculum exams. The patient will be consented and de-identified and assigned a number to their survey of four questions: 1. comfort level 2. last vaginal speculum exam 3. self-reported description of weight (underweight, normal, overweight, obese) 4. parity (number of births). The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans. Regulation Number: 884.4520