Status:
RECRUITING
Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Kidney Stones
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
Shengjing Hospital
The Third Xiangya Hospital of Central South University
Conditions:
Kidney Stones
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study, known as the FLAME Trial (Flexible ureteroscopy for Lower pole stones And Mini-pErcutaneous nephrolithotomy), is an international, multicenter, randomized, non-inferiority trial. It aims t...
Detailed Description
The FLAME Trial (Flexible ureteroscopy for Lower pole stones And Mini-pErcutaneous nephrolithotomy) is an international, multicenter, prospective, randomized, controlled, non-inferiority study that ai...
Eligibility Criteria
Inclusion
- Adults aged 18-75 years;
- American Society of Anesthesiology (ASA) score 1-3;
- Lower pole renal stones-single or multiple-with a maximal diameter of 1-2 cm confirmed by CT;
- Ability to provide written informed consent and adhere to trial requirements.
Exclusion
- Significant urinary tract anatomical anomalies (e.g. horseshoe kidney, ileal conduit);
- Stones located within a calyceal diverticulum;
- History of open nephrolithotomy or ureterolithomy (due to resultant intrarenal anatomical distortion);
- Absolute contraindications to either FANS-f-URS or mini-PCNL, including:
- Uncorrectable coagulopathy;
- Active, uncontrolled urinary tract infection;
- Severe cardiopulmonary disease precluding safe general anesthesia (e.g. decompensated heart failure, refractory COPD);
- Pregnancy;
- Inability to tolerate lithotomy or prone positioning;
- Inability to understand or complete trial documentation.
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT07159035
Start Date
August 28 2025
End Date
March 31 2026
Last Update
September 8 2025
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510230