The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
305
The research introducer will be used after the patient consents prior to the annual pap smear.
Healthy volunteer interviews
Duke University
Durham, North Carolina, United States
RECRUITINGAssessment of introducer
We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum
Time frame: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)
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