Coherence Imaging of the Cervical Epithelium

Not Applicable

Completed

• Conditions: Cervical Epithelia
• Interventions: Device: mLCI Device

• Registration Number: NCT02903394
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Study Start: 2016-10-27
• Primary Completion: 2017-10-24
• Study Completion: 2017-10-24
• Status Verified: 2018-10
• Results First Submitted: 2018-10-17
• Results First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Results First Posted: 2018-11-14
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mLCI imaging	mLCI Device	mLCI device images cervical epithelium

Primary Outcome Measures

Name	Time	Method
Number of Patients With Interferometric Data Acquired From Cervical Epithelium	day 1	measured by: ability to receive interferometric data from at least one portion of the cervical epithelium

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Automated Classification of Cervical Epithelium	day 1	The number of patients for which an interferometric tissue classification was made using optical mLCI data
Number and Frequency of Adverse Events	day 1	Number of adverse events experienced by patients during the mLCI study.

Trial Locations

Locations (1)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States