The Use of a Novel Vaginal Speculum for Cervical Cancer Screening in Sunrise Community Health Patients
NCT ID: NCT06496295
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
200 participants
OBSERVATIONAL
2024-11-14
2025-12-30
Brief Summary
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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.
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Detailed Description
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The clinician will be provided with a one-page Instructions for Use document and a 2-minute instructional video on how to use the Bouquet Speculum TM. 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 length of the study is anticipated to be three months. The surveys will be collected and tabulated and then evaluated by Dr. Mark Payton who has experience with the Pakistan study.
The Bouquet Speculum has been FDA-cleared and is a Class II medical device and poses a non-significant risk for use in humans.
Proprietary Name: Bouquet Vaginal Speculum Classification Name: RETRACTOR, VAGINAL Product Code: HDL Device Class:2 Regulation Number: 884.4520 Medical Specialty: Obstetrics/Gynecology Registered Establishment Name: Viospex Registered Establishment Number:3012447313 Owner/Operator: Viospex Owner/Operator Number:10051911 Establishment Operations: Manufacture
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Vaginal Speculum Exam
Evaluating the visibility of the cervix, ease-of-use, and comfort of a new vaginal speculum.
Eligibility Criteria
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Inclusion Criteria
* women ages 18-25
Exclusion Criteria
* lack of a uterine cervix
* no prior vaginal speculum exam
18 Years
65 Years
FEMALE
Yes
Sponsors
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Rocky Vista University, LLC
OTHER
Responsible Party
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Principal Investigators
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Jean Bouquet, DO
Role: PRINCIPAL_INVESTIGATOR
Rocky Vista University
Locations
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Rocky Vista University
Englewood, Colorado, United States
Countries
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References
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Bouquet JM, Naji R, Armas CA, Roldan V, Selkhi S, Bentley CZ, Zapata I, Fisher J. An Innovative Design for the Vaginal Speculum. Med Devices (Auckl). 2023 Sep 25;16:211-218. doi: 10.2147/MDER.S415558. eCollection 2023.
Related Links
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Publication in the Journal of Women's Health
Other Identifiers
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IRB #2023-266
Identifier Type: -
Identifier Source: org_study_id
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