Coherence Imaging of the Cervical Epithelium

NCT ID: NCT02903394

Last Updated: 2018-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-27

Study Completion Date

2017-10-24

Brief Summary

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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

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Conditions

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Cervical Epithelia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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mLCI imaging

mLCI device images cervical epithelium

Group Type EXPERIMENTAL

mLCI Device

Intervention Type DEVICE

imaging of cervical epithelium using mLCI device

Interventions

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mLCI Device

imaging of cervical epithelium using mLCI device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Jacobi Medical Center

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Wax, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Jacobi Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01CA167421

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00070555

Identifier Type: -

Identifier Source: org_study_id

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