Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT04107181

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Introducer "calla" device

Interviews only

Study Details

Brief summary:

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Conditions

Cervical Cancer

Study ID

NCT04107181

Start date

Apr 14, 2016

Status verified date

Mar, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

305 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

Introducer "calla" device

The research introducer will be used after the patient consents prior to the annual pap smear.

Interviews only

Healthy volunteer interviews

Primary outcome measure

  • Assessment of introducer [ Time Frame: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers) ]

Central Contacts and Locations

Central contacts

Nimmi Ramanujam, PhD

9196605307nimmi@duke.edu

Jennifer Gallagher, BA

9199701551jennifer.gallagher@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Nimmi Ramanujam, PhD

nimmi@duke.edu

Jennifer Gallagher, BA

9199701551jennifer.gallagher@duke.edu

More Information

Sponsor

Duke University

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • Pap smear

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-06.