Pilot Study for Speculum Free Cervical Cancer Screening

Study Overview
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Brief Summary
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The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Detailed Description
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This project is to assess if the introducer, calla, can be used in place of a speculum during a routine Pap smear. For the patient arm, the introducer will be used in conjunction with standard of care procedures. The healthy volunteer arm will include taking the introducer home for a week to determine if each person can find their cervix without the help of a physician. As well as completing surveys on ease of use and demographics related to their medial history.

Official Title
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A Pilot Study Continuation to Assess the Use of an Introducer Calla During Cervical Cancer Screening

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Introducer calla device
* Behavioral: Interviews only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female Aged 21-65 years Have had a pelvic exam Have conversational proficiency in English Highest level of education attained Exclusion Criteria: - Pregnant women

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient surveillance<br>The introducer will be used during annual Pap smears for cervical cancer screening. | Device: Introducer calla device<br>* The research introducer will be used after the patient consents prior to the annual pap smear.<br>|
| Experimental: Healthy Volunteers<br>There will be 2 types of healthy volunteers recruited to participate in this arm. The home study is to determine ease of use/feasibility of the introducer. The other group of healthy volunteers will be interviewed only. The goal of this study is to better understand how to improve women's health through learning about women's perceptions of their reproductive anatomy, specifically the cervix, comfort in discussing reproductive health topics with providers, and thoughts on two tools used to see the cervix. | Behavioral: Interviews only<br>* Healthy volunteer interviews<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of introducer | We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum | Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pap smear