TY - JOUR
T1 - A clinical evaluation of the new digital single-use flexible ureteroscope (UscopePU3022): An international prospective multicentered study
AU - Johnston, Thomas James
AU - Baard, Joyce
AU - de la Rosette, Jean
AU - Doizi, Steeve
AU - Giusti, Guido
AU - Knoll, Thomas
AU - Proietti, Silvia
AU - Brehmer, Marianne
AU - Emiliani, Esteban
AU - Pérez-Fentes, Daniel
AU - Osther, Palle Jorn Sloth
AU - Seitz, Christian
AU - Neal, Naomi
AU - Turney, Ben
AU - Hasan, Mudhar
AU - Traxer, Olivier
AU - Wiseman, Oliver
PY - 2018
Y1 - 2018
N2 - Introduction We assessed the clinical performance of a new digital single-use flexible ureteroscope (UscopePU3022). Material and methods A prospective cohort study was carried out across 11 centers (July–Oct. 2017). The UscopePU3022 was assessed regarding ease of insertion; deflection, image quality, maneuverability and overall performance using either a visual analog* or Likert scale. Results A total of 56 procedures were performed in 11 centers (16 surgeons) with the indication being renal stones in 83%. The median score for ease of scope insertion was 10 (3–10). Intraoperative maneuverability was rated as ‘good’ in 38% and ‘very good’ in 52%. Visual quality was rated as ‘poor or bad’ in 18%, ‘fair’ in 37% and ‘good or very good’ in 43%. Two scopes failed intraoperatively (4%). Preoperative and postoperative median upward and downward deflection was 270 degrees. Compared to standard flexible ureteroscopy (f-URS) maneuverability was rated as ‘equivalent’ in 30% and ‘better’ in 60%; visual quality was ‘worse’ in 38% and ‘equivalent or better’ in 62%; limb fatigue scores were ‘better’ in 86%; and overall performance was ‘worse’ in 55% and ‘equivalent or better’ in 45%. Conclusions UscopeTM3022 performed well with regards to maneuverability, deflection and limb fatigue and appears to be at least non-inferior to standard f-URS with regards to these parameters. Poor image quality is a concern for UscopePU3022 with it receiving a low overall performance rating when compared to standard f-URS. Despite this it scored highly when investigators were asked if they would use it in their practice if it was cost-effective to do so.
AB - Introduction We assessed the clinical performance of a new digital single-use flexible ureteroscope (UscopePU3022). Material and methods A prospective cohort study was carried out across 11 centers (July–Oct. 2017). The UscopePU3022 was assessed regarding ease of insertion; deflection, image quality, maneuverability and overall performance using either a visual analog* or Likert scale. Results A total of 56 procedures were performed in 11 centers (16 surgeons) with the indication being renal stones in 83%. The median score for ease of scope insertion was 10 (3–10). Intraoperative maneuverability was rated as ‘good’ in 38% and ‘very good’ in 52%. Visual quality was rated as ‘poor or bad’ in 18%, ‘fair’ in 37% and ‘good or very good’ in 43%. Two scopes failed intraoperatively (4%). Preoperative and postoperative median upward and downward deflection was 270 degrees. Compared to standard flexible ureteroscopy (f-URS) maneuverability was rated as ‘equivalent’ in 30% and ‘better’ in 60%; visual quality was ‘worse’ in 38% and ‘equivalent or better’ in 62%; limb fatigue scores were ‘better’ in 86%; and overall performance was ‘worse’ in 55% and ‘equivalent or better’ in 45%. Conclusions UscopeTM3022 performed well with regards to maneuverability, deflection and limb fatigue and appears to be at least non-inferior to standard f-URS with regards to these parameters. Poor image quality is a concern for UscopePU3022 with it receiving a low overall performance rating when compared to standard f-URS. Despite this it scored highly when investigators were asked if they would use it in their practice if it was cost-effective to do so.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85064907392&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30680241
U2 - https://doi.org/10.5173/ceju.2018.1787
DO - https://doi.org/10.5173/ceju.2018.1787
M3 - Article
C2 - 30680241
SN - 2080-4806
VL - 71
SP - 453
EP - 461
JO - Central European journal of urology
JF - Central European journal of urology
IS - 4
ER -