NCT04249856

Colposcopy and Dynamic Spectral Imaging (DSI)

Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the Dynamic Spectral Imaging (DSI) Colposcope (DySIS) in it's ability to diagnose cervical dysplasia. Half of participants with be examined by the DySIS colposcope, there the other half will be examined by standard colposcopy.

Detailed description

Colposcopy has been shown to be a subjective exam, and is dependant on the colposcopists. Sensitivity for colposcopy has been shown to be as low as 50%. To improve this, different adjunctive technologies have been introduced to add a more objective approach to the colposcopy exam. One of these devices is the DySIS colposcope, which measures the aceto-white reaction that may occur on the cervix uteri after the application of acetic-acid. The device provides the examiner with a colour-coded map indicating areas of interest. Studies have shown promising results indicating that using this device together with the colposcopists own interpretation of the cervix uteri can potentially lead to an increase in the performance of the colposcopy exam. In Denmark all women referred for colposcopy have 4 biopsies taken, according to the Danish national guidelines. In our study these 4 biopsies are as following: 1. The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB) 2. The area indicated as the worst by the DSI-map (DSI-directed biopsy) 3. additional biopsy 4. additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.

Conditions

• Cervical Dysplasia
• Cervical Disease
• Cervical Lesion
• Cervix Cancer
• Cervical Cancer
• Cervical Neoplasm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dynamic Spectral Imaging (DYSIS)	Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-06-01
• Completion: 2020-10-31
• First posted: 2020-01-31
• Last updated: 2020-01-31

Locations

4 sites across 1 country: Denmark

Regulatory

• FDA-regulated device study