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Completed

NCT Number: NCT07769450

Stone Cone Device vs. Standard URS for Proximal Ureteral Calculi

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.

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Key information

Conditions

Ureter Calculi

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provincial Headquarter Teaching Hospital, Gilgit.

Gilgit, Gilgit-Baltistan, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ureteroscopic Pneumatic Lithotripsy with Cone Device

Procedure

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.

Standard Ureteroscopic Pneumatic Lithotripsy

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.

Primary outcomes

  1. Stone Clearance Rate

    Time frame: 48 hours

    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.

Secondary outcomes

  1. Incidence of Intraoperative Complications

    Time frame: 2 hours

    The number of participants experiencing complications such as ureteral perforation or significant bleeding during the procedure.

  2. Operative Time

    Time frame: 120 minutes

    The total duration of the ureteroscopic procedure, measured in minutes.

  3. Hospital Stay Duration

    Time frame: 5 days

    The length of the patient's hospital stay following the procedure.

Sponsors and collaborators

Lead sponsor

Provincial Headquarter Teaching Hospital Gilgit

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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