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.

Study Overview

• Status: Completed
• Conditions: Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet Computer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 88

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

urologists and resident urologist

Description

Inclusion Criteria:

• urologist or resident urologist

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intra observer variability in delineated areas between the same bladder areas in different SPIES modalities.	1 hour
Inter observer variability in delineated areas between the same bladder areas in different SPIES modalities.	1 hour
Image quality of images in different SPIES modalities	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences in time to start delineation between images in different SPIES modalities	1 hour
Differences in time needed per image in different SPIES modalities	1 hour
Differences in use of úndo' button between different SPIES modalities	1 hour
Differences in participants who are familiar with image enhancement system (NBI/SPIES) vs participants who are not familiar working with them.	1 hour
Differences in interpretation of images between participants with a visual impairment or colourblindness vs participants without.	1 hour
Differences in interpretations between participants in age or experience in TURBT annually.	1 hour

Collaborators and Investigators

• Sponsor: Clinical Research Office of the Endourological Society

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2014-6