Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

Completed · Not applicable

Conditions studied: Cervical Dysplasia

In brief

The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine: 1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells. 2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).

Key facts

Study ID

NCT03502798

Run by

Duke University

People needed

45

Starts

2018-11-08

Expected to finish

2020-02-14

Last updated by the study team

2021-02-18

Who can join

Age: 21 and older. 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
• 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
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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