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Completed
NCT07769450
Stone Cone Device vs. Standard URS for Proximal Ureteral Calculi
Conditions: Ureter Calculi
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Provincial Headquarter Teaching Hospital Gilgit
Location: Provincial Headquarter Teaching Hospital, Gilgit. Gilgit Gilgit-Baltistan
Summary
Retrograde migration of stone fragments into the kidney during ureteroscopic lithotripsy (URS) for proximal ureteral stones is a common technical challenge, occurring in 5-40% of cases. This can lead to residual fragments and lower stone-free rates. The Stone Cone is an anti-retropulsion device designed to trap fragments and prevent their migration. This study will test the hypothesis that the use of the Stone Cone during URS pneumatic lithotripsy will result in a significantly higher stone clearance rate at 48 hours post-procedure compared to the standard technique without the device.
Eligibility Criteria
Inclusion Criteria:
* A solitary proximal ureteral stone ≤ 2 cm in size as confirmed by imaging.
* Normal renal function.
Exclusion Criteria:
* Active urinary tract infection (clinical features or pyuria).
* Bleeding disorder (abnormal prothrombin time or activated partial thromboplastin time).
* Chronic kidney disease (raised urea and creatinine).
* Stone \> 2 cm in size.
Source: ClinicalTrials.gov (NCT07769450). StuddyBuddy aggregates publicly available trial information.