Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Mini‑PCNL versus flexible ureteroscopy with a suction sheath for 2–3 cm kidney stones

Official title: Flexible Ureteroscopy Using a Tip-Bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Renal Stones: A Randomized Controlled Trial

Run by Ain Shams University · NCT07306819 · Data updated 2026-11-12

This tests whether mini‑PCNL or flexible ureteroscopy with a suction sheath better clears 2–3 cm kidney stones and leads to fewer complications in adults.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorAin Shams University
Academic / other
Locations1 site (Cairo)
StatusRecruiting
StartedOctober 15, 2025
Main results expectedAugust 15, 2026
Study endsSeptember 15, 2026
Registry record updatedDecember 29, 2025
Trial IDNCT07306819 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with kidney stones measuring 2–3 cm on CT who are eligible for either mini‑PCNL or flexible ureteroscopy and meet the study's inclusion/exclusion criteria.

Probably not a fit

Patients with uncontrolled diabetes, hypertension, hepatic dysfunction, renal failure, active urinary infection, bleeding disorders, pregnancy, prior ureteric injury, or certain congenital renal anomalies are excluded and unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial assigns adults with 2–3 cm renal stones to either mini‑percutaneous nephrolithotomy (mini‑PCNL) or flexible ureteroscopy (FURS) using a navigable suction sheath. Mini‑PCNL creates a small tract through the back into the kidney to directly visualize and remove stones with a miniature nephroscope. FURS is performed through the urinary tract using a thin flexible scope that incorporates suction to help capture and remove fragments and limit retropulsion. The primary outcome is stone‑free rate on post‑operative imaging, with secondary outcomes including operative time, length of hospital stay, and complication rates.

Why it matters

Potential benefit: If successful, the results could guide patients and surgeons to the procedure that achieves higher stone‑free rates with fewer complications and shorter hospital stays.

How similar studies have gone: Prior comparisons generally show higher stone‑free rates for percutaneous approaches with larger stones, while suction‑enabled ureteroscopes have promising early results but limited randomized evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patients aging 18 years old or more.
* Patients with renal stones between 2-3 cm in size confirmed by CT scan.

Exclusion Criteria:

* Patients with previous ureteric injury.
* Patients with uncontrolled diabetes mellitus or hypertension.
* Patients with uncontrolled hepatic dysfunction.
* Patients with uremia or renal failure.
* Pregnant patients.
* patients with active urinary tract infection.
* Patients with bleeding tendency or uncontrolled coagulopathy.
* Patients with congenital anomalies as horse-shoe kidney and pelvi-ureteric junction obstruction.

Where it's running

  • Ain shams university hospitals
    Cairo, Egypt
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.