Colposcopy and Dynamic Spectral Imaging (DSI)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cervical Cancer
- Cervical Disease
- Cervical Dysplasia
- Cervical Lesion
- Cervical Neoplasm
- Cervix Cancer
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 devic...
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: The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB) The area indicated as the worst by the DSI-map (DSI-directed biopsy) additional biopsy additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.
Tracking Information
- NCT #
- NCT04249856
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Berit B Booth, MD University of Aarhus Study Chair: Pinar Bor, MD, PhD Randers Regional Hospital Study Chair: Lone K Petersen, MD, Med.Sc.D. Odense University Hospital Study Chair: Jan Blaakaer, MD, Med.Sc.D. Odense University Hospital Study Chair: Katja Dahl, MD, PhD Aarhus University Hospital