Ì-SPIES, Comparison of Cystoscopy Images in Four Different SPIES Modalities

NCT02174302 | Completed

• 1 other identifier: 2014-6
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Comparison of Images of the Same Area in the Bladder in Four Different SPIES Modalities on a Tablet Computer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

urologists and resident urologist

You may qualify if:

• urologist or resident urologist

You may not qualify if:

• none

Sponsors & Collaborators

• Clinical Research Office of the Endourological Society: lead

Related Links

• Related Info

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 25, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2014-06