Pilot Study for Speculum Free Cervical Cancer Screening
Calla
A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
2 other identifiers
interventional
305
1 country
1
Brief Summary
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2016
CompletedFirst Submitted
Initial submission to the registry
September 11, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
March 6, 2026
March 1, 2026
11.8 years
September 11, 2019
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Patient surveillance
EXPERIMENTALThe introducer will be used during annual Pap smears for cervical cancer screening.
Healthy Volunteers
EXPERIMENTALThere 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.
Interventions
The research introducer will be used after the patient consents prior to the annual pap smear.
Eligibility Criteria
You may qualify if:
- Healthy female
- Aged 21-65 years
- Have had a pelvic exam
- Have conversational proficiency in English
- Highest level of education attained
You may not qualify if:
- \- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Duke Universitylead
- Korle-Bu Teaching Hospital, Accra, Ghanacollaborator
Study Sites (1)
Duke University
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nimmi Ramanujam, PhD
Duke
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2019
First Posted
September 27, 2019
Study Start
April 14, 2016
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share