Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retro… (NCT06729801) | Clinical Trial Compass
CompletedNot Applicable
Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery
China100 participantsStarted 2024-01-01
Plain-language summary
This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. The primary outcomes include IRP monitoring accuracy, operative time, stone-free rate (SFR), and complication rates, with the aim of improving stone retrieval efficiency and procedural safety in RIRS. This trial seeks to validate the innovative device's role in expanding RIRS indications, especially for large renal stones.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult patients (18-75 years old) diagnosed with renal stones (size ≤4 cm) and suitable for retrograde intrarenal surgery (RIRS).
✓. Willing to provide informed consent.
✓. No significant renal, cardiac, or systemic diseases that may interfere with the surgical procedure or the study.
✓. Preoperative intravenous pyelography (IVP) showing no significant ureteral stricture.
Exclusion criteria
✕. Patients with active urinary tract infections (UTIs) or fever at the time of surgery.
✕. Pregnancy or breastfeeding women.
✕. Patients with a history of severe renal disease (e.g., chronic kidney disease stage 3 or higher).
✕. History of prior ureteral or renal surgery that may affect the anatomy.
✕. Patients with uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.
What they're measuring
1
Operative Time
Timeframe: Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).
Trial details
NCT IDNCT06729801
SponsorThe First Affiliated Hospital of Guangzhou Medical University