Adding a New Device for Comfortable Cervical Cancer Screening
NCT04107181 · RecruitingThis study looks at whether a new device called "calla" can help with cervical cancer screening. It aims to see if this device can replace a speculum during a Pap smear. Researchers want to learn about how well this device works and how easy it is for women to use it.
Locations and contact
This trial is running at 1 location in the United States. It is currently recruiting.
United States1 location · 1 recruiting
- Duke UniversityDurham, North CarolinaRecruiting
Who can join
Women aged 21 to 65 who are healthy can join. They must have had a pelvic exam and be able to speak English. Pregnant women cannot take part. The team will check eligibility for everyone.
What happens during the trial
Participants will be in one of two groups. One group will use the "calla" device during their Pap smears. The other group will help by taking the device home for a week to see if they can find their cervix without a doctor. They will also answer questions about their experience.
The trial team
The trial is run by Duke University. It also works with Korle-Bu Teaching Hospital in Ghana and the National Cancer Institute. Dr. Nimmi Ramanujam from Duke is the main investigator.
Important dates
The study started on April 14, 2016, and is expected to finish by February 1, 2028. It is currently recruiting new participants.
Additional information
The trial's ID number is NCT04107181. This study is not in a specific phase and is regulated by the FDA for the device used. About 305 people are expected to take part.
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