Pilot Study for Speculum Free Cervical Cancer Screening
NCT ID: NCT04107181
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
305 participants
INTERVENTIONAL
2016-04-14
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Patient surveillance
The introducer will be used during annual Pap smears for cervical cancer screening.
Introducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear.
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.
Interviews only
Healthy volunteer interviews
Interventions
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Introducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear.
Interviews only
Healthy volunteer interviews
Eligibility Criteria
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Inclusion Criteria
* Aged 21-65 years
* Have had a pelvic exam
* Have conversational proficiency in English
* Highest level of education attained
Exclusion Criteria
21 Years
65 Years
FEMALE
Yes
Sponsors
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Korle-Bu Teaching Hospital, Accra, Ghana
OTHER
National Cancer Institute (NCI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Nimmi Ramanujam, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00008173_1
Identifier Type: -
Identifier Source: org_study_id
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