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NCT04107181 Clinical Trial

Pilot Study for Speculum Free Cervical Cancer Screening

Cervical Cancer Clinical Trial

— Calla  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04107181
Other study ID # Pro00008173_1
Secondary ID R01CA239268-04
Status Recruiting
Phase N/A
First received
Last updated
Start date April 14, 2016
Est. completion date February 1, 2025

Study information
Verified date January 2024
Source Duke University
Contact Nimmi Ramanujam, PhD
Phone 9196605307
Email nimmi@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 305
Est. completion date February 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Introducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear.
Behavioral:
• Interviews only
Healthy volunteer interviews

Locations
Country Name City State
United States Duke University Durham North Carolina

Sponsors (3)
Lead Sponsor Collaborator
Duke University Korle-Bu Teaching Hospital, Accra, Ghana, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of introducer 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)
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