Coherence Imaging of the Cervical Epithelium

Completed · Not applicable

Conditions studied: Cervical Epithelia

In brief

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.

Key facts

Study ID

NCT02903394

Run by

Duke University

People needed

55

Starts

2016-10-27

Expected to finish

2017-10-24

Last updated by the study team

2018-11-14

Who can join

Age: 18 and older, up to 36. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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