Coherence Imaging of the Cervical Epithelium
2 other identifiers
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedStudy Start
First participant enrolled
October 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2017
CompletedResults Posted
Study results publicly available
November 14, 2018
CompletedNovember 14, 2018
October 1, 2018
12 months
September 1, 2016
October 17, 2018
October 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
day 1
Secondary Outcomes (2)
Number of Patients With Automated Classification of Cervical Epithelium
day 1
Number and Frequency of Adverse Events
day 1
Study Arms (1)
mLCI imaging
EXPERIMENTALmLCI device images cervical epithelium
Interventions
Eligibility Criteria
You may qualify if:
- able to provide informed consent
- willing to abstain from sexual intercourse for at least 24 hours before study visit
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Cancer Institute (NCI)collaborator
- Jacobi Medical Centercollaborator
Study Sites (1)
Jacobi Medical Center
The Bronx, New York, 10461, United States
Results Point of Contact
- Title
- Kengyeh Chu
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Wax, Ph.D.
professor
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2016
First Posted
September 16, 2016
Study Start
October 27, 2016
Primary Completion
October 24, 2017
Study Completion
October 24, 2017
Last Updated
November 14, 2018
Results First Posted
November 14, 2018
Record last verified: 2018-10