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NCT04107181NARecruitingAccepts Healthy Volunteers

Pilot Study for Speculum Free Cervical Cancer Screening

Duke University

Start Date

4/14/2016

Completion Date

2/1/2028

Summary

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

Detailed Description

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.

Eligibility Criteria

Age Range: 21 years to 65 years

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

Interventions

DEVICE

Introducer "calla" device

BEHAVIORAL

Interviews only

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Conditions

Cervical Cancer

Locations

Duke University

Durham, North Carolina 27710

United States