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Clinical Trials/KCT0007506
KCT0007506Completed未知

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

EasyEndo Surgical0 sites47 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
47
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional Study

Eligibility Criteria

Ages
19(Year) to 80(Year) (—)
Sex
All

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

Investigators

Sponsor
EasyEndo Surgical

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