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.

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NCT04107181

Pilot Study for Speculum Free Cervical Cancer Screening

Recruiting
NAAges 21–65InterventionalScreening
Duke University
~305 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:Introducer "calla" deviceInterviews only

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of introducer
Measured over Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)
Cervical Cancer
1 sites across 1 states
North Carolina1
  • Nimmi Ramanujam, PhD · PRINCIPAL_INVESTIGATOR · Duke

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Eligibility criteria

Inclusion

Aged 21-65 years
Have had a pelvic exam
Have conversational proficiency in English
Highest level of education attained
  • 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