Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT07159035
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Kidney Stones
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
Study Overview
Official Title:
Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Renal Stones: an International, Multicenter, Randomized Non-Inferiority Trial (FLAME Trial)
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLAME
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 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.
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.
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 aims to evaluate the safety and efficacy of flexible ureteroscopy assisted by a Flexible and Navigable Suction Ureteral Access Sheath (FANS) compared with mini-percutaneous nephrolithotomy (mini-PCNL) in the treatment of 1-2 cm lower pole renal stones.
This trial will enroll 640 patients from 20 urology centers with substantial experience in endoscopic stone surgery, including hospitals in China, Russia, Turkey, and India. Eligible participants will be randomly assigned in a 1:1 ratio to either the FANS-assisted flexible ureteroscopy group or the mini-PCNL group. All patients will undergo preoperative imaging, intraoperative standardization, and postoperative follow-up according to the study protocol.
The primary endpoint is the stone-free rate (SFR) within 72 hours postoperatively, evaluated by non-contrast-enhanced computed tomography (NCCT). Secondary endpoints include SFR at 1 month, operative time, length of hospital stay, postoperative pain (measured by VAS score), complication rates (graded by Clavien-Dindo classification), changes in renal function, and health-related quality of life (HRQoL).
The FANS, developed to improve irrigation control and active stone fragment suction during flexible ureteroscopy, may provide better visualization, reduce intrarenal pressure, and shorten operative time. By directly comparing FANS-assisted fURS with mini-PCNL, the trial seeks to determine whether a less invasive method can achieve comparable outcomes in terms of stone clearance and complication rates.
This trial will enroll 640 patients from 20 urology centers with substantial experience in endoscopic stone surgery, including hospitals in China, Russia, Turkey, and India. Eligible participants will be randomly assigned in a 1:1 ratio to either the FANS-assisted flexible ureteroscopy group or the mini-PCNL group. All patients will undergo preoperative imaging, intraoperative standardization, and postoperative follow-up according to the study protocol.
The primary endpoint is the stone-free rate (SFR) within 72 hours postoperatively, evaluated by non-contrast-enhanced computed tomography (NCCT). Secondary endpoints include SFR at 1 month, operative time, length of hospital stay, postoperative pain (measured by VAS score), complication rates (graded by Clavien-Dindo classification), changes in renal function, and health-related quality of life (HRQoL).
The FANS, developed to improve irrigation control and active stone fragment suction during flexible ureteroscopy, may provide better visualization, reduce intrarenal pressure, and shorten operative time. By directly comparing FANS-assisted fURS with mini-PCNL, the trial seeks to determine whether a less invasive method can achieve comparable outcomes in terms of stone clearance and complication rates.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: