Pilot Study for Speculum Free Cervical Cancer Screening (Calla)

January 8, 2024 updated by: Duke University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

305

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nimmi Ramanujam, PhD
  • Phone Number: 9196605307
  • Email: nimmi@duke.edu

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient surveillance
The introducer will be used during annual Pap smears for cervical cancer screening.
Device: Introducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear.
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.
Behavioral: Interviews only
Healthy volunteer interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

  • Principal Investigator: Nimmi Ramanujam, PhD, Duke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2016

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008173_1
  • R01CA239268-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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