A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
Duke University
Summary
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
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
- Age range
- 21–65 years
- Sex
- Female
- Healthy volunteers
- Yes
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
- DeviceIntroducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear.
- BehavioralInterviews only
Healthy volunteer interviews
Location
- Duke UniversityDurham, North Carolina