ZedScan Clinical Trials
Identification and detection of cervical disease
The ability to identify correctly those women who have and those who do not have disease is pivotal to the success of any screening programme. Prevention of cervical cancer depends on colposcopic detection and treatment of high-grade cervical intra-epithelial neoplasia (CIN 2+) in women referred with abnormal cytology.
A number of clinical studies have been completed to assess the performance of an EIS based diagnostic device in the diagnosis of cervical intraepithelial neoplasia (CIN) – Table 1.
Table 1: Clinical studies involving the use of an EIS device in the assessment of the cervix
| Publication | Patients Recruited |
|---|---|
| British Journal of Obstetrics and Gynaecology, (March, 2013)* | 429 |
| Gynecological Oncology, (2009) | 104 |
| International Journal of Gynecological Cancer, (2006) | 176 |
| British Journal of Obstetrics and Gynaecology, (2005) | 87 |
| Lancet, (2000) | 124 |
Please refer to the relevant publication for an in-depth analysis of the data.
*Conclusion from pivotal multicentre trial:
" The use of EIS as an real-time adjunct to colposcopy improves clinical performance. The inclusion of EIS into colposcopic practice could lead to more appropriate patient management with lower intervention rates.
Principal Investigators:
Prof. Henry Kitchener
Prof. Walter Prendiville
Prof. John Tidy