MedTrace Logo

Pilot Study for Speculum Free Cervical Cancer Screening

NCT04107181 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2026-03-06

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Korle-Bu Teaching Hospital, Accra, Ghana

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Nimmi Ramanujam, PhD · Duke

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2028-02-01
Completion
2028-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107181 on ClinicalTrials.gov