A Pilot Study Continuation to Assess the Use of an Introducer Calla During Cervical Cancer Screening
Who is this study for? Adult female patients that have undergone a pelvic exam
Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: t
View:
⁃ Healthy female
• Aged 21-65 years
• Have had a pelvic exam
• Have conversational proficiency in English
• Highest level of education attained
Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Nimmi Ramanujam, PhD
nimmi@duke.edu
9196605307
Backup
Jennifer Gallagher, BA
jennifer.gallagher@duke.edu
9199701551
Time Frame
Start Date: 2016-04-14
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 305
Treatments
Experimental: Patient surveillance
The introducer will be used during annual Pap smears for cervical cancer screening.
Experimental: Healthy Volunteers
There will be 2 types of healthy volunteers recruited to participate in this arm. The home study is to determine ease of use/feasibility of the introducer. The other group of healthy volunteers will be interviewed only. The goal of this study is to better understand how to improve women's health through learning about women's perceptions of their reproductive anatomy, specifically the cervix, comfort in discussing reproductive health topics with providers, and thoughts on two tools used to see the cervix.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: Korle-Bu Teaching Hospital, Accra, Ghana, National Cancer Institute (NCI)