Cervical cancer screening without a speculum
A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
This study is testing a new device that could replace the traditional speculum during Pap smears to see if it makes cervical cancer screening easier and more effective for women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 305 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04107181 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of the 'calla' introducer as a replacement for the traditional speculum during routine Pap smears. The study will involve two groups: one receiving the introducer along with standard care, and another group of healthy volunteers who will use the introducer at home to locate their cervix independently. Participants will also complete surveys regarding their experience and medical history. The goal is to determine the optical signatures of cervical dysplasia using innovative optical technologies.
Who should consider this trial
Good fit: Ideal candidates are healthy females aged 21-65 who have previously undergone a pelvic exam.
Not a fit: Pregnant women will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this approach could make cervical cancer screening more comfortable and accessible for women.
How similar studies have performed: While this approach is innovative, similar studies have not been widely conducted, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Nimmi Ramanujam, PhD — Duke
- Study coordinator: Nimmi Ramanujam, PhD
- Email: nimmi@duke.edu
- Phone: 9196605307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.