N/A
N=55
Coherence Imaging of the Cervical Epithelium
Cervical Epithelia
Bottom Line
View on ClinicalTrials.gov: NCT02903394 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Patients With Interferometric Data Acquired From Cervical Epithelium — 3; 41 patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mLCI Device (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Interferometric Data Acquired From Cervical Epithelium |
3; 41 | — |
| SECONDARY Number of Patients With Automated Classification of Cervical Epithelium |
36 | — |
| SECONDARY Number and Frequency of Adverse Events |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02903394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.