Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Pilot Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Operative Time
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Patients who are unwilling or unable to comply with the study protocol.
Outcomes
Primary Outcomes
Operative Time
Time Frame: Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).
The primary outcome will be the total operative time, measured from the insertion of the endoscope into the urethra to the completion of stent placement. This outcome will assess the efficiency of stone retrieval when using either the IRP-monitoring FANS or the conventional FANS.
Secondary Outcomes
- Stone-Free Rate (SFR)(24-48 hours post-surgery, based on CT scan results.)
- Postoperative Complications(Evaluated within 30 days post-surgery.)
Investigators
Guohua Zeng
Vice president
The First Affiliated Hospital of Guangzhou Medical University