Published in:
01-08-2017 | Original Article
First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris™): a European prospective multicenter study
Published in: World Journal of Urology | Issue 8/2017
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Purpose
We evaluated a new single-use digital flexible cystoscope with an integrated grasper designed for double-J stent removal, Isiris™, addressing success rate, image quality, deflection, maneuverability and grasper functionality.
Methods
In September 2015, a prospective cohort study was conducted in six tertiary European reference centers. All consecutive patients included underwent double-J stent removal and were 18 years or older. Success rate was defined by complete stent removal. Image quality, deflection, maneuverability and grasper functionality were rated with a Likert scale.
Results
A total of 83 procedures were performed. 82% of procedures were performed in the endoscopy room, while the others were in the operating room since a consecutive endourological intervention was planned. The median duration of stent implantation was 28 days [14; 60]. In five patients, stent removal was not possible. Four patients had an incrusted double-J stent, and in one patient, the stent migrated into the ureter. After unsuccessful attempts of stent removal with conventional flexible cystoscope and grasper, the five patients had to be scheduled for an ureterorenoscopy procedure to remove the stent. In the other 78 patients, all double-J stents were removed successfully. Image quality, deflection, maneuverability and grasper functionality were rated as “very good” in 72.3, 78.3, 72.3 and 73.5%, respectively.
Conclusion
This multicenter clinical evaluation of Isiris™ displayed good image quality, active deflection, maneuverability and grasper functionality. Further evaluation of stent removal outcomes, cost analysis and microbiology will help to delineate the possible place of Isiris™ in the current practice.