Actively Recruiting
RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones
Led by Changhai Hospital · Updated on 2025-07-10
308
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
X
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. The aim is to evaluate the clinical efficacy and safety of the novel suction sheath-assisted RIRS compared to standard PCNL in terms of stone-free rate and postoperative complications. A total of 308 patients will be enrolled across four centers in China.
CONDITIONS
Official Title
RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- American Society of Anesthesiologists (ASA) physical status classification of I-III
- Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan
- Signed written informed consent and willingness to comply with study procedures
You will not qualify if you...
- Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit)
- Uncontrolled urinary tract infection
- Absolute contraindications for RIRS or PCNL
- Inability to understand or complete study documentation
- Failure to follow study protocol or attend follow-up
- Patients requiring urgent rescue or at high risk for irreversible harm during surgery
- Patients who voluntarily withdraw from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
X
Xiaofeng Gao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here