N/A
N=45
Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
Cervical Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT03502798 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies — 90.3; 100.0 percentage of correct identifications
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- scanning a/LCI (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies |
90.3; 100.0 | — |
| PRIMARY Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies |
81.6; 70.6 | — |
| SECONDARY Identification of T-zone by Scanning a/LCI Probe |
— | — |
Summary
The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine:
1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells.
2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).
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
- 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 (NCT03502798). 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.