NCT07622238 IAU Percutaneous Nephrolithotripsy Study
| NCT ID | NCT07622238 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Foundation Endourology |
| Condition | Urolithiasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2019-08-15 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2019-08-15 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
During the past 10-15 years, important advancements have been witnessed in percutaneous nephrolithotomy (PCNL) techniques and instrumentation. The development of miniaturized PCNL techniques and modern laser technologies has contributed to lower complication rates, alongside changes in exiting strategies and postoperative drainage protocols. Ultrasound is increasingly utilized to create percutaneous access, and many medical centers have transitioned to the supine position for PCNL or perform Endoscopic Combined Intrarenal Surgery (ECIRS). All these developments have helped to individualize treatment strategies and to improve clinical outcomes for patients. However, there remains an ongoing discussion regarding the optimal indications and limitations of the different miniaturized PCNL techniques compared to standard PCNL and retrograde intrarenal surgery (RIRS). This prospective observational study is organized under the auspices of the International Alliance of Urolithiasis (IAU) and focuses on the contemporary indications, surgical techniques, instrumentation, exiting strategies, efficacy, and risk factors for intraoperative and postoperative complications of PCNL. Participating investigators will collect data on the PCNL procedures performed in their respective clinical centers prospectively for a period of 12-18 months. The study will be initiated in each clinical center following formal approval from the IAU Scientific Committee, which will also announce the conclusion of the study.
Eligibility Criteria
Inclusion Criteria: * Patient age 18 years or older at the time of enrollment. * Diagnosed with single or multiple renal calculi (including complex and staghorn calculi) or proximal ureteral stones. * Scheduled to undergo any primary or secondary percutaneous surgical stone intervention, including standard percutaneous nephrolithotomy (PCNL) or any of its miniaturized variations (Mini-PCNL, Ultra-mini PCNL, Super-mini PCNL, or Micro-PCNL). * Voluntarily provided written informed consent for participation and data utilization. Exclusion Criteria: * Patient age under 18 years. * Patients scheduled to undergo alternative primary treatment modalities for the targeted stone burden as a standalone procedure (e.g., retrograde intrarenal surgery \[RIRS\] or shockwave lithotripsy \[SWL\]). * Presence of an active, untreated urinary tract infection (UTI) or clinical urosepsis at the time of the scheduled surgical procedure. * Uncorrected severe coagulopathy or uncorrectable bleeding diathesis. * Missing, incomplete, or unavailable medical charts or follow-up records rendering outcome assessment impossible.
Contact & Investigator
Kemal Sarika, PhD
STUDY CHAIR
Sancaktepe Training and Research Hospital, Istanbul, Turkiye
Frequently Asked Questions
Who can join the NCT07622238 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Urolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07622238 currently recruiting?
Yes, NCT07622238 is actively recruiting participants. Contact the research team at iliya.saltirov@gmail.com for enrollment information.
Where is the NCT07622238 trial being conducted?
This trial is being conducted at Sofia, Bulgaria, Sofia, Bulgaria, Sofia, Bulgaria, Sofia, Bulgaria.
Who is sponsoring the NCT07622238 clinical trial?
NCT07622238 is sponsored by Foundation Endourology. The principal investigator is Kemal Sarika, PhD at Sancaktepe Training and Research Hospital, Istanbul, Turkiye. The trial plans to enroll 4,000 participants.