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

The Bouquet Speculum TM will be used by a variety of clinicians at Sunrise Clinics including physicians, PAs, and NPs for routine cervical cancer screening including Pap tests and/or HPV probes. 200 women will be selected from the Sunrise Clinics in the Denver-Metro area. Women who do not have a cervix or have never had a vaginal speculum exam will be excluded. The inclusion criteria is women ages 18-65.

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

Inclusion criteria

• 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