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COMPLETED
NCT07769450
NA

Stone Cone Device vs. Standard URS for Proximal Ureteral Calculi

Sponsor: Provincial Headquarter Teaching Hospital Gilgit

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial Comparing Stone Clearance and Retrograde Migration in Ureteroscopic Pneumatic Lithotripsy for Proximal Ureteral Calculi Performed With and Without the Stone Cone Anti-Retropulsion Device

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-10-01

Completion Date

2026-06-30

Last Updated

2026-08-18

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Ureteroscopic Pneumatic Lithotripsy with Cone Device

Patients will undergo ureteroscopic pneumatic lithotripsy under general anesthesia. The Stone Cone device (Boston Scientific, Natick, MA) will be advanced through the ureteroscope and positioned fluoroscopically proximal to the calculus before fragmentation. The device will create a mechanical barrier to prevent retrograde stone migration into the renal pelvis and will be used to trap and extract fragments upon withdrawal. A ureteral double-J stent will be placed at the end of the procedure.

PROCEDURE

Standard Ureteroscopic Pneumatic Lithotripsy

Patients will undergo standard ureteroscopic pneumatic lithotripsy under general anesthesia without the use of any anti-retropulsion device. Stone fragmentation and fragment extraction will be performed using standard tools (pneumatic lithotripter, grasping forceps, or basket) as per the surgeon's discretion. A ureteral double-J stent will be placed at the end of the procedure.

Locations (1)

Provincial Headquarter Teaching Hospital, Gilgit.

Gilgit, Gilgit-Baltistan, Pakistan