Coherence Imaging of the Cervical Epithelium

October 17, 2018 updated by: Duke University
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • able to provide informed consent
  • willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion Criteria:

  • pregnant
  • using an intrauterine device (IUD)
  • have a current gynecological infection or discharge
  • have had any cervical surgery
  • had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
  • currently enrolled in any research studies involving the application of vaginal formulations
  • employed or supervised by the study investigators
  • have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mLCI imaging
mLCI device images cervical epithelium
Device: mLCI Device
imaging of cervical epithelium using mLCI device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
Time Frame: day 1
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Automated Classification of Cervical Epithelium
Time Frame: day 1
The number of patients for which an interferometric tissue classification was made using optical mLCI data
day 1
Number and Frequency of Adverse Events
Time Frame: day 1
Number of adverse events experienced by patients during the mLCI study.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)
Jacobi Medical Center

Investigators

  • Principal Investigator: Adam Wax, Ph.D., Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2016

Primary Completion (Actual)

October 24, 2017

Study Completion (Actual)

October 24, 2017

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00070555
  • R01CA167421 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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