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临床试验/NCT02174302
NCT02174302已完成不适用

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

Clinical Research Office of the Endourological Society0 个研究点目标入组 88 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
主要终点
Inter observer variability in delineated areas between the same bladder areas in different SPIES modalities.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • urologist or resident urologist

排除标准

  • 未提供

结局指标

主要结局

Inter observer variability in delineated areas between the same bladder areas in different SPIES modalities.

时间窗: 1 hour

Image quality of images in different SPIES modalities

时间窗: 1 hour

Intra observer variability in delineated areas between the same bladder areas in different SPIES modalities.

时间窗: 1 hour

次要结局

  • 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)
  • 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)

研究者

发起方
Clinical Research Office of the Endourological Society
申办方类型
Other
责任方
Sponsor

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