Actively Recruiting

Age: 18Years - 100Years
All Genders
ID07622238

International Alliance of Urolithiasis Percutaneous Nephrolithotripsy Study

Led by Foundation Endourology · Updated on 2026-06-03

4000

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

F

Foundation Endourology

Lead Sponsor

T

The International Alliance of Urolithiasis

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the current use, effectiveness, and safety of percutaneous nephrolithotomy (PCNL) for treating kidney stones. This observational study, led by the International Alliance of Urolithiasis (IAU), aims to evaluate different PCNL techniques, including miniaturized versions, and compare them to standard methods. The study also seeks to identify risk factors for complications during and after surgery, using a standardized classification system to assess outcomes. Participants undergo PCNL procedures according to their clinical center's protocols, which use various imaging methods like ultrasound or fluoroscopy to access the kidney. Techniques include standard and miniaturized PCNL performed in different patient positions, with details recorded on tract dilation methods, lithotripsy energy types, and drainage strategies after surgery. The study collects data over 12 to 18 months at multiple centers worldwide, with oversight by the IAU Scientific Committee and an audit team for quality control. During the study, participants' clinical data are entered securely by local coordinators at each site. Researchers collect detailed preoperative, intraoperative, and postoperative information, including imaging results, stone characteristics, surgical details, complication rates, hospital stay duration, and kidney function changes. The primary outcome is the stone-free rate one month after surgery, with secondary measures including complication rates within 30 days, hemoglobin changes, operative time, and length of hospital stay. The study plans to include up to 10,000 patients to better understand PCNL outcomes and safety.

CONDITIONS

Brief Title

IAU Percutaneous Nephrolithotripsy Study

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age 18 years or older at the time of enrollment
  • Diagnosed with single or multiple renal calculi or proximal ureteral stones
  • Scheduled to undergo any primary or secondary percutaneous surgical stone intervention including standard or miniaturized PCNL
  • Provided written informed consent for participation and data use
Not Eligible

You will not qualify if you...

  • Patient age under 18 years
  • Scheduled for alternative primary treatments such as retrograde intrarenal surgery or shockwave lithotripsy alone
  • Presence of active, untreated urinary tract infection or clinical urosepsis at surgery
  • Uncorrected severe coagulopathy or bleeding disorders
  • Missing or incomplete medical records preventing outcome assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey: What to Expect

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants undergo percutaneous nephrolithotomy (PCNL) surgery for treatment of kidney stones. The procedure involves creating a tract to the kidney to remove stones using various techniques and instruments based on clinical practice at each center.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 30 days postoperatively

Participants are monitored for up to 30 days after surgery to assess complications, recovery, and stone-free status. This includes hospital stay and postoperative care.

Approximately 1 to 2 visits depending on hospital stay and recovery

Trial Site Locations

Total: 4 locations

1

Foundation Endourology

Sofia, Sofia-Grad, Bulgaria, 1606

Actively Recruiting

2

Foundation Endourology

Sofia, Sofia-Grad, Bulgaria, 1606

Actively Recruiting

3

Foundation Endourology

Sofia, Sofia-Grad, Bulgaria, 1606

Actively Recruiting

4

Military Medical Academy, Department of Urology and Nephrology

Sofia, Sofia-Grad, Bulgaria, 1606

Actively Recruiting

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Research Team

I

Iliya P Saltirov, DSc

O

Ognyan H Gatsev, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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