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.
Brief Title
Coherence Imaging of the Cervical Epithelium
Completion Date
Completion Date Type
Actual
Conditions
Cervical Epithelia
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* able to provide informed consent
* willing to abstain from sexual intercourse for at least 24 hours before study visit
* able to provide informed consent
* willing to abstain from sexual intercourse for at least 24 hours before study visit
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
36 Years
Minimum Age
18 Years
NCT Id
NCT02903394
Org Class
Other
Org Full Name
Duke University
Org Study Id
Pro00070555
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Coherence Imaging of the Cervical Epithelium
Primary Outcomes
Outcome Description
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
Outcome Measure
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
Outcome Time Frame
day 1
Secondary Ids
Secondary Id
R01CA167421
Secondary Outcomes
Outcome Description
The number of patients for which an interferometric tissue classification was made using optical mLCI data
Outcome Time Frame
day 1
Outcome Measure
Number of Patients With Automated Classification of Cervical Epithelium
Outcome Description
Number of adverse events experienced by patients during the mLCI study.
Outcome Time Frame
day 1
Outcome Measure
Number and Frequency of Adverse Events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
36
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Zinaman
Investigator Email
Investigator Phone