Use of electrical impedance spectroscopy as an adjunct to colposcopy in a pathway of cervical intraepithelial neoplasia diagnostics

Abstract

Objectives: Screening with cytology decreases cervical cancer burden, but new methods have emerged. We assessed the diagnostic value of electrical impedance spectroscopy (EIS) in the real-world gynecological setting. The study aimed to determine the diagnostic usefulness of EIS used as an adjunct to colposcopies in the diagnosis of high-grade squamous intraepithelial lesions in women with abnormal cytology findings. Material and methods:A cross-sectional, single center, observational study considered 143 women. All were subjected to a colposcopy and EIS with ZedScan. ZedScan-guided or colposcopically-guided biopsies were carried out.Results: Data from 118 women were analyzed. The average age of the included women was 38.29 ± 12.52 years (range: 22-86 years). Overall, 27 had a diagnosis of CIN2+ and above on histopathological examination, 99 had low-grade colposcopy results, 18 had high-grade colposcopy results, and 80 had positive ZedScan examination. No adverse events related to the examination with ZedScan were observed. EIS used as an adjunct to colposcopies showed sensitivity of 96.30% (95% CI: 81.03-99.91) and specificity of 39.56% (95% CI: 29.46-50.36), and accuracy of 52.54% (95% CI: 43.15-61.81). The procedure allowed to detect 11 additional cases with positive histo-pathological result in comparison to colposcopies alone. Conclusions:Colposcopies performed with ZedScan as an adjunct were effective in detecting high-grade cervical lesions. Advantages of ZedScan include real-time result display, no additional diagnostic burden posed on the patient, and good safety profile. Studies on large patient cohorts are needed for further evaluations of this diagnostic procedure and factors which may affect its diagnostic accuracy.

Increased detection of high grade CIN, when using electrical impedance spectroscopy as an adjunct to routine colposcopy, is maintained when used across international boundaries: Prospective data from nine European countries

“…EIS is sensitive to the cellular structure of the epithelium and offers information that is not available to visual examination. ZedScan incorporates EIS and can be used as a real time adjunct to colposcopy with multiple studies confirming increased detection of HG-CIN [5][6][7][8][9][10][11]. However, data from clinical trials and cohort studies are not always confirmed when a technology is implemented across multiple healthcare settings with variations in disease prevalence.…”

Effect of melatonin on electrical impedance and biomarkers of damage in a gastric ischemia/reperfusion model

“…The EIS has the ability to show morphological alterations in tissue under I/R conditions in different neoplastic organs and processes [24][25][26]. Additionally, it has been shown to have the sensibility to detect cellular changes related to the processes of proliferation, re-epithelization, regeneration, and healing in both in vitro and in vivo models [27][28][29][30].…”

A novel digital rectoscope for the triage of lower gastrointestinal symptoms in primary care: a prospective multicentre feasibility study

“…Because this study was designed to assess feasibility with qualitative end-points and determine the practicalities of trial delivery for a subsequent phase III study, this approach was deemed appropriate and of similar size to a comparable investigational point-of-care technology study. 16 Analysis of quantitative data were performed on an as-treated basis and on an intention-to-treat basis in the qualitative domains. Variables were expressed as median and interquartile range (IQR), and the χ 2 and Kruskal-Wallis tests were used to compare categorical non-parametric data between groups.…”

“…A 10% attrition rate was calculated, setting the final recruitment target of 110 over five months. Because this study was designed to assess feasibility with qualitative end-points and determine the practicalities of trial delivery for a subsequent Phase III study, this approach was deemed appropriate and of similar size to comparable investigational point-of-care technology studies(16). Analysis of quantitative data was performed on an as treated basis and on an intention-to-treat basis in the qualitative domains.…”