NCT07058402 RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones
| NCT ID | NCT07058402 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | Nephrolithiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 308 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04-30 |
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
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 308 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04-30.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 80 years 2. American Society of Anesthesiologists (ASA) physical status classification of I-III 3. Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan 4. Signed written informed consent and willingness to comply with study procedures Exclusion Criteria: 1. Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit) 2. Uncontrolled urinary tract infection 3. Absolute contraindications for RIRS or PCNL 4. Inability to understand or complete study documentation 5. Failure to follow study protocol or attend follow-up 6. Patients requiring urgent rescue or at high risk for irreversible harm during surgery 7. Patients who voluntarily withdraw from the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07058402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Nephrolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07058402 currently recruiting?
Yes, NCT07058402 is actively recruiting participants. Contact the research team at gxfdoc@sina.com for enrollment information.
Where is the NCT07058402 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07058402 clinical trial?
NCT07058402 is sponsored by Changhai Hospital. The trial plans to enroll 308 participants.