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First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study

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Abstract

Introduction

We evaluated a new digital single-use flexible ureteroscope, LithoVue™ with respect to deflection, image quality and maneuverability.

Methods

A prospective cohort study was conducted in eight tertiary reference centers in Europe in December 2015 and January 2016. All consecutive patients included underwent flexible ureteroscopy and were 18 years or older. Deflection and image quality pre- and post-use and maneuverability were rated with a Likert scale.

Results

A total of 40 procedures were performed (five per institution). The indication for FURS was treatment of renal stones in 92.5 % of the cases. Before LithoVue™ usage, the median measured upward and downward deflections were both 270°. Image quality was rated as “very good” in 65 % of cases and “good” in 30 %. Maneuverability was “very good” in 77.5 % and “good” in 17.5 %. At the final evaluation, median upward and downward deflections were both 270°. Image quality was still “very good” in 65 % of cases and “good” in 30 % with no significant difference compared with preoperative data (p = 1). Maneuverability was “very good” in 72.5 % and “good” in 17.5 %, with no significant difference compared with preoperative data (p = 0.92). Two LithoVue™ broke during surgery (5 %): one occurring in extreme deflection with acute infundibulopelvic angle and spontaneous loss of vision for the second one.

Conclusion

The LithoVue™ displayed good image quality, active deflection and maneuverability. Further evaluation of surgical outcomes and cost analysis will help to present the best utility of this single-use FURS in current practice.

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Acknowledgments

The authors would like to thank Boston Scientific for providing LithoVue endoscopes in each center in order to evaluate its performance.

Authors’ contribution

Doizi contributed to protocol/project development, data collection or management, data analysis and manuscript writing/editing; Kamphuis contributed to protocol/project development, data collection or management, data analysis and manuscript writing/editing; Giusti contributed to protocol/project development, data collection or management and manuscript writing/editing; Knoll contributed to protocol/project development, data collection or management and manuscript writing/editing; Osther contributed to protocol/project development, data collection or management and manuscript writing/editing; Scoffone contributed to protocol/project development, data collection or management and manuscript writing/editing; Pérez Fentes contributed to protocol/project development, data collection or management and manuscript writing/editing; Proietti contributed to protocol/project development, data collection or management and manuscript writing/editing; Wiseman contributed to protocol/project development, data collection or management and manuscript writing/editing; de la Rosette contributed to protocol/project development, data collection or management and manuscript writing/editing; and Traxer contributed to protocol/project development, data collection or management and manuscript writing/editing.

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Author notes

    Authors and Affiliations

    1. Department of Urology, Tenon Hospital, Assistance-Publique Hôpitaux de Paris, Paris, France

      Steeve Doizi & Olivier Traxer

    2. Pierre et Marie Curie University, Paris, France

      Steeve Doizi & Olivier Traxer

    3. Groupe de Recherche Clinique sur la Lithiase Urinaire, Tenon Hospital, Assistance Publique – Hôpitaux de Paris, Paris, France

      Steeve Doizi & Olivier Traxer

    4. Department of Urology, Academic Medical Center, Amsterdam, The Netherlands

      Guido Kamphuis & Jean de la Rosette

    5. Ville Turro Division, Department of Urology, IRCCS San Raffaele Scientific Institute, Milan, Italy

      Guido Giusti & Silvia Proietti

    6. Department of Urology, Lillebaelt Hospital, University of Southern Denmark, Fredericia, Denmark

      Kim Hovgaard Andreassen & Palle Jörn Osther

    7. Department of Urology, Klinikum Sindelfingen-Böblingen, Sindelfingen, Germany

      Thomas Knoll

    8. Department of Urology, Cottolengo Hospita, Turin, Italy

      Cesare Scoffone

    9. Department of Urology, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago De Compostela, Spain

      Daniel Pérez-Fentes

    10. Department of Urology, Addenbrooke’s Hospital, Cambridge, UK

      Oliver Wiseman

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    1. Steeve Doizi
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    Corresponding author

    Correspondence to Steeve Doizi.

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    Conflict of interest

    Steeve Doizi, None; Guido Kamphuis, None; Guido Giusti, Boston Scientific, Coloplast, Cook Medical, Olympus, Karl Storz, Rocamed; Thomas Knoll, Boston Scientific, Palle Jörn Osther, Boston Scientific, Coloplast, Olympus, Karl Storz; Cesare Scoffone, Boston Scientific, Coloplast, Cook Medical, Lumenis, Karl Storz; Daniel Pérez-Fentes, Boston Scientific, Coloplast; Silvia Proietti, None; Oliver Wiseman, Boston Scientific, Coloplast, EMS, Olympus; Jean de la Rosette, Boston Scientific, Coloplast, Olympus, Karl Storz; Olivier Traxer, Boston Scientific, Coloplast, Lumenis, Olympus, Rocamed.

    Ethical approval

    “All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.”

    Informed consent

    “Informed consent was obtained from all individual participants included in the study.”

    Additional information

    Steeve Doizi and Guido Kamphuis have contributed equally.

    Appendix: Checklist used during each procedure for LithoVue™ evaluation

    Appendix: Checklist used during each procedure for LithoVue™ evaluation

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    Doizi, S., Kamphuis, G., Giusti, G. et al. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. World J Urol 35, 809–818 (2017). https://doi.org/10.1007/s00345-016-1936-x

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    • DOI: https://doi.org/10.1007/s00345-016-1936-x

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