Clinical trial · Interventional
Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| scanning a/LCI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- scanning a/LCI
- interventionNames
- Device: scanning a/LCI
Primary outcomes (2)
- measure
- Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
- timeFrame
- baseline
- description
- Sensitivity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified positive optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous epithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
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