Pilot Study for Speculum-Free Cervical Cancer Screening
This study is testing a new device called "calla" that aims to replace the speculum during a routine Pap smear for cervical cancer screening. The study is looking for women aged 21-65 who are generally healthy and have had a pelvic exam. You would either use the "calla" device during your Pap smear, or, if you're a healthy volunteer, take the device home for a week to see if you can find your cervix without a doctor's help. The main goal is to see how well the "calla" introducer works. The study plans to enroll 305 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study with an unspecified phase, planning to enroll 305 participants. It has two arms: one for patients undergoing a Pap smear and another for healthy volunteers.
- What's involved
- If you are a patient, the "calla" device will be used during your Pap smear. If you are a healthy volunteer, you will take the device home for a week and complete surveys.
- Compensation
- Not stated in the trial record.
- Follow-up
- The assessment of the introducer will be measured up to one week after the Pap smear for patients, and up to one week for healthy volunteers.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot Study for Speculum Free Cervical Cancer Screening
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nimmi Ramanujam, PhD · PRINCIPAL_INVESTIGATOR · Duke
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Assessment of introducerUp 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