NCT Number: NCT02174302
Ì-SPIES, Comparison of Cystoscopy Images in Four Different SPIES Modalities
Comparison of Images of the same area in the bladder in four different SPIES modalities on a tablet computer. Participants are asked to delineate the area on the image suspect for malignancy as precise as possible with a stylus on the tablet screen. Delineated area(s) is/are captured. Time to start the drawing and total time per image are captured. Hereafter, an judgement of Image quality is asked on a scale of 0 to 10, 0 being worst possible and 10 being best possible.
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Notify MeKey information
Sex eligibility
All sexes
Study type
Observational
About this study
Karl Storz Company has recently introduced the Storz Professional Image Enhancement System. To evaluate the interpretation of cystoscopy images in different SPIES modalities a tablet program was developed. Images of 20 bladder areas were captured in 4 different SPIES modalities; white light, Clara&Chroma, Spectra A and Spectra B. Of each bladder area, one extra image was added to the program, so that a total of 100 images were interpreted.
Every image is shown 45 seconds on the tablet screen. Participants are asked to delineate with a stylus on the tablet the precise area they suspect to be malignant and would resect or treat. After they are done they go to the next slide and the time is stopped.After each image, participants are asked to judge the quality of the image on a scale of zero to ten, with zero being the worst and ten the best.After this judgement, the next image for interpretation is presented.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- urologist or resident urologist
Exclusion criteria
- none
Treatment and study plan
Primary outcomes
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Intra observer variability in delineated areas between the same bladder areas in different SPIES modalities.
Time frame: 1 hour
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Inter observer variability in delineated areas between the same bladder areas in different SPIES modalities.
Time frame: 1 hour
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Image quality of images in different SPIES modalities
Time frame: 1 hour
Secondary outcomes
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Differences in time to start delineation between images in different SPIES modalities
Time frame: 1 hour
-
Differences in time needed per image in different SPIES modalities
Time frame: 1 hour
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Differences in use of úndo' button between different SPIES modalities
Time frame: 1 hour
-
Differences in participants who are familiar with image enhancement system (NBI/SPIES) vs participants who are not familiar working with them.
Time frame: 1 hour
-
Differences in interpretation of images between participants with a visual impairment or colourblindness vs participants without.
Time frame: 1 hour
-
Differences in interpretations between participants in age or experience in TURBT annually.
Time frame: 1 hour
Sponsors and collaborators
Lead sponsor
Clinical Research Office of the Endourological Society
Other
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jun 25, 2014
- Registry last updated
- Jun 25, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.