An interventional study of Ureteroscopic Pneumatic Lithotripsy with Cone Device and Standard Ureteroscopic Pneumatic Lithotripsy in Ureter Calculi, sponsored by Provincial Headquarter Teaching Hospital Gilgit. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Provincial Headquarter Teaching Hospital Gilgit · Not applicable, Interventional, and Treatment
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.
51 studies on the registry are indexed under Calculi; 6 are open to participants now.
This study's enrollment of 100 is above the median of 74 across 43 interventional studies indexed under Calculi.
Browse Calculi studies →Provincial Headquarter Teaching Hospital Gilgit is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo ureteroscopic pneumatic lithotripsy for a proximal ureteral calculus. The Stone Cone device will be positioned fluoroscopically proximal to the stone before fragmentation and used to prevent retrograde stone migration and trap fragments for extraction.
Procedure: Ureteroscopic Pneumatic Lithotripsy with Cone Device
Participants will undergo standard ureteroscopic pneumatic lithotripsy for a proximal ureteral calculus without the use of any anti-retropulsion device.
Procedure: Standard Ureteroscopic Pneumatic Lithotripsy
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.
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.
Stone Clearance Rate
The proportion of participants achieving a stone-free status, defined as the absence of stones on plain X-ray of the kidneys, ureters, and bladder (KUB) and abdominal ultrasonography performed 48 hours after the ureteroscopic lithotripsy procedure.
Time frame: 48 hours
Incidence of Intraoperative Complications
The number of participants experiencing complications such as ureteral perforation or significant bleeding during the procedure.
Time frame: 2 hours
Operative Time
The total duration of the ureteroscopic procedure, measured in minutes.
Time frame: 120 minutes
Hospital Stay Duration
The length of the patient's hospital stay following the procedure.
Time frame: 5 days
Plan to share: No — Individual participant data will not be shared with other researchers due to institutional policies regarding patient confidentiality and data protection. Additionally, the trial is a single-center study with a modest sample size, and the research team does not have an established infrastructure for data-sharing or the necessary resources to support external data requests.
No publications or documents are linked to this record.
Ran from Oct 2022 to primary completion in Apr 2026, 42 months.
Of 16 interventional studies with no phase under Calculi, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 60. This study's 42 months is close to that.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Provincial Headquarter Teaching Hospital Gilgit