Multi-center, Prospective, Single Arm, Pivotal study to evaluate the efficacy and safety of ‘easyUretero 100’, robotic-assisted surgery system in patients in need of Retrograde Intrarenal Surgery

Not Applicable

Completed

• Conditions: Diseases of the genitourinary system

• Registration Number: KCT0007506
• Lead Sponsor: EasyEndo Surgical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-13
• Last Update Posted: 20 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

The subjects must satisfy all of the following inclusion criteria for enrollment.

1.The subjects must be adults between the age of 19 and 80 years old who require RIRS due to renal stones that are difficult to remove naturally through non-surgical treatment
2.They must have one or more renal stones with a maximum size between 5 mm and 30 mm
3.They must voluntarily decide to participate in this clinical trial and provide written consent
4.They must be willing to comply with the clinical trial protocol

Exclusion Criteria

The subjects who satisfy any of the following exclusion criteria may not participate in this clinical trial.

1.Those who cannot discontinue anti-coagulants or anti-platelet drugs, excluding aspirin
2.Those who have bilateral stones and who require simultaneous removal
3.Those who must undergo other interventional surgeries upon RIRS, such as for prostatic hypertrophy, ureteropelvic junction obstruction, ureteral stricture, ureteral carcinoma, calyceal diverticulum, and others
4.Those who would have difficulties to undergo RIRS due to abnormalities in the anatomical structure of the ureter
5.Those who underwent renal replacement therapy, through transplantation
6.Those who were diagnosed with chronic kidney disease
7.Those with active urinary tract infection (UTI)
8.Pregnant women
9.Those who are hypersensitive to contrast agents and whose responses are difficult to control
10.Those who have difficulties in undergoing local and general anesthesia
11.Those who are currently participating or have participated in another clinical trial within 30 days from the screening date
12.Those who may otherwise affect the results and are considered unfit for this clinical trial, upon the discretion of the investigator
? In these cases, the detailed reasons should be recorded in the case report form

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical success rate ;Adverse Events

Secondary Outcome Measures

Name	Time	Method
reter injury rate ;Operation time ;Complication rate ;Operator fatigue, strain, and satisfaction;Conversion rate to classic RIRS