Coherence Imaging of the Cervical Epithelium

Duke University

Status: Completed

Conditions: Cervical Epithelia

Treatments: Device: mLCI Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02903394

Pro00070555

R01CA167421 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

mLCI imaging

Experimental group

Description:

mLCI device images cervical epithelium

Treatment:

Device: mLCI Device