Surgery in Motion A New Robot for Flexible Ureteroscopy: Development and Early Clinical Results (IDEAL Stage 1–2b) Remzi Saglam a , Ahmet Yaser Muslumanoglu b , Zafer Tokatlı a , Turhan C ¸ as ¸ kurlu c , Kemal Sarica d , Ali I ˙ hsan Tas ¸ c ¸ i e , Bu ¨lent Erkurt f , Evren Su ¨er g , Ahmet Sinan Kabakci h , Glenn Preminger i , Olivier Traxer j , Jens J. Rassweiler k,l, * a Department of Urology, Medicana International Hospital, Ankara, Turkey; b Department of Urology, Bagcilar Training Hospital, Istanbul, Turkey; c Department of Urology, Medeniyet University Hospital, Istanbul, Turkey; d Department of Urology, Kartal Training Hospital, Istanbul, Turkey; e Department of Urology, Bakırko ¨y Training Hospital, Istanbul, Turkey; f Department of Urology, Medipol University Medical School Hospital, Istanbul, Turkey; g Department of Urology, Ankara University Medical School Hospital, Ankara, Turkey; h Department of Bioengineering, Hacettepe University, Ankara, Turkey; i Division of Urologic Surgery, Duke University Medical Center, Durham, NC, USA; j Department of Urology, Universite ´ Pierre et Marie Curie, Hoˆpital Tenon, Paris, France; k Department of Urology, SLK Kliniken Heilbronn, Heilbronn, Germany; l Department of Urology, University of Heidelberg, Heidelberg, Germany E U R O P E A N U R O L O G Y X X X ( 2 0 1 4 ) X X X – X X X ava ilable at www.sciencedirect.com journa l homepage: www.europea nurology.com Article info Article history: Accepted June 27, 2014 Keywords: Robotics Telesurgery Surgical manipulator Urolithiasis Ureterorenoscopy Retrograde intrarenal surgery Ergonomics Please visit www.europeanurology.com and www.urosource.com to view the accompanying video. Abstract Background: An improved armamentarium has had a significant impact on the emerging role of flexible ureteroscopy (FURS) for the management of nephrolithiasis; however, FURS still represents a challenging technique. Objective: To examine a robotic device designed for FURS for its impact on ergonomics and outcome of the procedure based on the IDEAL (idea, development, evaluation, assessment, long-term study) framework. Design, setting, and participants: Roboflex Avicenna consists of a surgeon’s console and a manipulator for the flexible ureterorenoscope. Following experimental evaluation of the prototype (IDEAL stage 1) and receipt of ethical approval, seven surgeons treated 81 patients (mean age: 42 yr [range: 6–68]) with renal calculi (mean volume: 1296 Æ 544 mm 3 [range: 432–3100 mm 3 ]) in an observational study (IDEAL stage 2). Surgical procedure: Robotic FURS was performed with the Roboflex Avicenna robotic device. Outcome measurements and statistical analysis: Numerical data were analysed with the Mann-Whitney test, and categorical variables were analysed using the chi-square test or Fisher exact test. P values <0.05 were considered statistically significant. Results and limitations: Mean robot docking time was 59.6 Æ 45 s. Mean operative time was 74 min (range: 40–182). Mean fragmentation speed was 29.1 Æ 6.1 mm 3 /min. Ergonom- ics based on a validated questionnaire showed significant advantage for robotic FURS (total score: 5.6 vs 31.3; p < 0.01). A 10/12F-access sheath was used in 72 patients. Two cases required secondary FURS, one because of malfunction of the flexible digital ureteroscope and another because of larger residual fragments. In the remaining 79 cases, complete stone disintegration was accomplished. Conclusions: Roboflex Avicenna provides a suitable and safe platform for robotic FURS with significant improvement of ergonomics. Future studies should evaluate its impact on the clinical outcome of FURS. Patient summary: Robotic flexible ureteroscopy (FURS) was performed with the Roboflex Avicenna robotic device. Results showed that Roboflex Avicenna provides a suitable and safe platform for robotic FURS with significant improvement of ergonomics. # 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Department of Urology, SLK-Kliniken Heilbronn, 74078 Heilbronn, Germany. Tel. +49 7131492401; Fax: +49 7131492429. E-mail address: jens.rassweiler@slk-kliniken.de (J.J. Rassweiler). EURURO-5719; No. of Pages 9 Please cite this article in press as: Saglam R, et al. A New Robot for Flexible Ureteroscopy: Development and Early Clinical Results (IDEAL Stage 1–2b). Eur Urol (2014), http://dx.doi.org/10.1016/j.eururo.2014.06.047 http://dx.doi.org/10.1016/j.eururo.2014.06.047 0302-2838/# 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.