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OpenTrials
Completed

NCT Number: NCT02903394

Coherence Imaging of the Cervical Epithelium

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.

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Key information

Conditions

Cervical Epithelia

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mLCI Device

Device

imaging of cervical epithelium using mLCI device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Number and Frequency of Adverse Events

    Time frame: day 1

    Number of adverse events experienced by patients during the mLCI study.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Jacobi Medical Center
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.