Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

Status:	Recruiting
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	21 - Any
Updated:	11/14/2018
Start Date:	November 8, 2018
End Date:	April 2019
Contact:	Adam Wax, Ph.D.
Email:	a.wax@duke.edu
Phone:	919-660-5143

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).

Inclusion Criteria:

- able to provide informed consent

- willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion Criteria:

- 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

We found this trial at

sites

Jacobi Medical Center

1400 Pelham Parkway South
Bronx, New York 10461

(718) 918-5000