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Clinical evaluation of a device providing simultaneous white-light and fluorescence video streams as well as panoramic imaging during fluorescence assisted-transurethral resection of bladder cancer.
Journal of the Optical Society of America A ( IF 1.9 ) Pub Date : 2019-11-01 , DOI: 10.1364/josaa.36.000c62
Marine Amouroux , Julia Salleron , Cécile Huin-Schohn , Sharib Ali , Stéphane Berthaud , Philippe Rizo , Sylvain Schneider , Christine Vever-Bizet , Geneviève Bourg-Heckly , François Guillemin , Patricia Le Coupanec , Ernest Galbrun , Joël Daouk , Christian Daul , Walter Blondel , Pascal Eschwège

The current clinical study is aimed at evaluating the clinical relevance of an innovative device (called CyPaM2 device) that for the first time provides urologists with (i) a panoramic image of the bladder inner wall within the surgery time, and with (ii) a simultaneous (bimodal) display of fluorescence and white-light video streams during the fluorescence assisted-transurethral resection of bladder cancers procedure. The clinical relevance of this CyPaM2 device was evaluated on 10 patients according to three criteria (image quality, fluorescent lesions detection relevance, and ergonomics) compared with a reference medical device. Innovative features displayed by the CyPaM2 device were evaluated without any possible comparison: (i) simultaneous bimodal display of white-light and fluorescence video streams, (ii) remote light control, and (iii) time delay for the panoramic image building. The results highlight the progress to achieve in order to obtain a fully mature device ready for commercialization and the relevance of the innovative features proposed by the CyPaM2 device confirming their interest.

中文翻译:

在膀胱癌的荧光辅助经尿道切除术中同时提供白光和荧光视频流以及全景成像的设备的临床评估。

当前的临床研究旨在评估创新设备(称为CyPaM2设备)的临床相关性,该设备首次为泌尿科医师提供(i)手术时间内膀胱内壁的全景图像,以及(ii)在膀胱癌手术的荧光辅助经尿道切除术中同时(双峰)显示荧光和白光视频流。与参考医疗设备相比,根据3个标准​​(图像质量,荧光损伤检测相关性和人体工程学)对10位患者评估了此CyPaM2设备的临床相关性。对CyPaM2设备显示的创新功能进行了评估,没有进行任何可能的比较:(i)同时显示白光和荧光视频流的双峰显示;(ii)远程光控制;(iii)建立全景影像的时间延迟。结果突出显示了为获得可用于商业化的完全成熟的设备而取得的进展,以及CyPaM2设备提出的创新功能的相关性证实了它们的兴趣。
更新日期:2019-11-04
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