Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07159035

Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Kidney Stones

Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2025-09-08

640

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Guangzhou Medical University

Lead Sponsor

S

Shengjing Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 to compare the effectiveness and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the treatment of 1-2 cm lower pole kidney stones. A total of 640 eligible adult patients will be enrolled across 20 high-volume urology centers in China, Russia, Turkey, and India. Participants will be randomly assigned to undergo either FANS-assisted flexible ureteroscopy or mini-PCNL. The primary outcome is the immediate stone-free rate (SFR) assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include SFR at 1 month, operative time, pain score, length of hospital stay, complication rates, and changes in health-related quality of life. The goal of this trial is to determine whether the less invasive FANS-assisted approach is non-inferior to mini-PCNL in terms of efficacy, while potentially offering advantages in postoperative recovery and safety.

CONDITIONS

Official Title

Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Kidney Stones

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-75 years
  • ASA (American Society of Anesthesiology) score between 1 and 3
  • Lower pole kidney stones, single or multiple, with size 1-2 cm confirmed by CT scan
  • Ability to provide written informed consent and follow the study procedures
Not Eligible

You will not qualify if you...

  • Significant urinary tract anatomical abnormalities (e.g., horseshoe kidney, ileal conduit)
  • Stones located within a calyceal diverticulum
  • History of open nephrolithotomy or ureterolithomy
  • Absolute contraindications to FANS-assisted flexible ureteroscopy or mini-PCNL, including uncorrectable bleeding disorders, uncontrolled urinary tract infection, severe heart or lung disease preventing safe general anesthesia, pregnancy, or inability to tolerate lithotomy or prone positions
  • Inability to understand or complete study documents

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510230

Actively Recruiting

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Research Team

W

Wei Zhu, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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