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Stone Cone Device vs. Standard URS for Proximal Ureteral Calculi

NCT07769450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Ureter Calculi

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.

Sponsors & Collaborators

  • Provincial Headquarter Teaching Hospital Gilgit

    lead OTHER

Principal Investigators

  • Khawar Suliman, MBBS, FCPS · Provincial Headquarter Teaching Hospital Gilgit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769450 on ClinicalTrials.gov