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
Conditions
Cervical Cancer
Locations
Duke University
Durham, North Carolina 27710
United States