Cervical Cancer
Conditions
Keywords
Pap smear
Brief 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.
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
Sponsors
Duke University
Korle-Bu Teaching Hospital, Accra, Ghana
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of introducer | Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers) | We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum |
Countries
United States
Contacts
CONTACTNimmi Ramanujam, PhD
CONTACTJennifer Gallagher, BA
PRINCIPAL_INVESTIGATORNimmi Ramanujam, PhD
Duke
Outcome results
None listed