Abstract
Purpose
To objectively and subjectively assess the performance and surgical outcomes of the new Innovex EU-scope™ single-use digital flexible ureteroscope (fURS).
Methods
A prospective cohort study was carried out (August 2019 to May 2020). The new single-use fURS (Innovex Medical Devices Co. Shanghai, China) was analysed with regard to visibility, manoeuvrability, laser interference and overall performance using a validated Likert scale. Outcomes are compared to the LithoVue™ (Boston Scientific, Marlborough, MA).
Results
One hundred patients were included in this study. 50 cases underwent retrograde fURS using the Innovex EU-scope™ and 50 with the LithoVue™. There were no differences in the patient demographics data, or operative data between the two groups. The Innovex EU-scope™ scored higher visibility scores compared to the LithoVue™, median 4, interquartile range (IQR) (4–4), vs. 3.5, IQR (3–5), p = 0.5086. Both scopes had similar manoeuvrability scores. The Innovex EU-scope™ scored significantly lower with regard to comfort compared to the LithoVue, median 4 IQR (3–4) vs. 4.5 IQR (4–5), p = 0.0445. Whereas, laser interference, affected the Innovex much less than the LithoVue™. Both scopes scored well for overall performance. The median overall performance score for the Innovex was 4 IQR (4–4) vs. 4 IQR (4–5).
Conclusions
This Innovex EU-scope™ has good objective and subjective visibility and manoeuvrability profiles. This single-use flexible ureteroscope may achieve similar clinical outcomes to an established single use instrument.
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Data availability
Available on request.
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DH and KP created the report concept, performed data analysis and wrote the initial manuscript. KP and FD performed data collection. DH and KP performed literature review. MH, LCY, ME, KP, and KB guided the scope and approach of the study and refined the manuscript. DH performed statistical analyses. All authors refined the final manuscript, and agree to be accountable for all aspects of the work.
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Patterson, K., Yap, L.C., Elamin, M. et al. Evaluation of a new disposable flexible ureterorenoscope and comparison to an established disposable flexible ureterorenoscope: a prospective, observational study. Int Urol Nephrol 53, 875–881 (2021). https://doi.org/10.1007/s11255-020-02727-0
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DOI: https://doi.org/10.1007/s11255-020-02727-0