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Pilot Study for Speculum Free Cervical Cancer Screening (Calla)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04107181
Recruitment Status : Suspended (COVID-19)
First Posted : September 27, 2019
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Korle-Bu Teaching Hospital, Accra, Ghana
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: Introducer "calla" device Behavioral: Interviews only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 305 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
Actual Study Start Date : April 14, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107181


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Korle-Bu Teaching Hospital, Accra, Ghana
Investigators
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Principal Investigator: Nimmi Ramanujam, PhD Duke
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04107181    
Other Study ID Numbers: Pro00008173_1
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Duke University:
Pap smear
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female