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Pilot Study for Speculum Free Cervical Cancer Screening (Calla)

Primary Purpose

Cervical Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Introducer "calla" device

Interviews only

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Pap smear

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patient surveillance

Healthy Volunteers

Arm Description

The introducer will be used during annual Pap smears for cervical cancer screening.

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.

Outcomes

Primary Outcome Measures

Assessment of introducer

We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum

Secondary Outcome Measures

Full Information

NCT ID

NCT04107181

First Posted

September 11, 2019

Last Updated

January 24, 2023

Sponsor

Duke University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04107181

Brief Title

Pilot Study for Speculum Free Cervical Cancer Screening

Acronym

Calla

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 14, 2016 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

Pap smear

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

305 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient surveillance

Arm Type

Experimental

Arm Description

The introducer will be used during annual Pap smears for cervical cancer screening.

Arm Title

Healthy Volunteers

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Introducer "calla" device

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Interviews only

Intervention Description

Healthy volunteer interviews

Primary Outcome Measure Information:

Title

Assessment of introducer

Description

We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum

Time Frame

Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nimmi Ramanujam, PhD

Phone

9196605307

nimmi@duke.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Gallagher, BA

Phone

9199701551

jennifer.gallagher@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nimmi Ramanujam, PhD

Organizational Affiliation

Duke

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nimmi Ramanujam, PhD

nimmi@duke.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Gallagher, BA

Phone

9199701551

jennifer.gallagher@duke.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pilot Study for Speculum Free Cervical Cancer Screening

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