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

NCT ID: NCT02174302

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* urologist or resident urologist

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Research Office of the Endourological Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Related Links

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Other Identifiers

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2014-6

Identifier Type: -

Identifier Source: org_study_id

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