Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

Duke University

Status: Completed

Conditions: Cervical Dysplasia

Treatments: Device: scanning a/LCI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03502798

Pro00070555_1

R01CA167421 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: Female

Ages: 21+ 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
• 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: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

scanning a/LCI

Experimental group

Treatment:

Device: scanning a/LCI