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Recruiting

NCT Number: NCT04107181

Pilot Study for Speculum Free Cervical Cancer Screening

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

Recruiting

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This project is to assess if the introducer, "calla", can be used in place of a speculum during a routine Pap smear. For the patient arm, the introducer will be used in conjunction with standard of care procedures. The healthy volunteer arm will include taking the introducer home for a week to determine if each person can find their cervix without the help of a physician. As well as completing surveys on ease of use and demographics related to their medial history.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Introducer "calla" device

Device

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

Interviews only

Behavioral

Healthy volunteer interviews

Primary outcomes

  1. Assessment of introducer

    Time frame: Up 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Gallagher, BA

CONTACT

[email protected]

9199701551

Nimmi Ramanujam, PhD

CONTACT

[email protected]

9196605307

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Korle-Bu Teaching Hospital, Accra, Ghana
  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening

Acronym: Calla

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Sep 27, 2019
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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