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6.3Fr Versus 7.5Fr Mini-Flexible Ureteroscopy for Renal Stones (MINI-FURS)
Sponsor: Sault Area Hospital
Summary
This prospective, randomized, single-blinded, non-inferiority clinical trial will compare the clinical outcomes and cost-effectiveness of two mini-flexible ureteroscopes (6.3Fr and 7.5Fr) used during flexible ureteroscopy for the treatment of renal stones. Adult patients with renal stones up to 15 mm who are scheduled to undergo flexible ureteroscopy will be randomly assigned to one of the two study groups. The primary objectives are to compare stone-free rates and the ability to achieve primary renal access without preoperative ureteral stenting. Secondary outcomes include operative time, fluoroscopy use, ureteral trauma, postoperative stenting, pain, complications, emergency department visits, need for additional procedures, hospital stay, and cost-effectiveness. The results of this study are expected to provide high-quality evidence to guide the selection of mini-flexible ureteroscopes and improve the quality, safety, and value of surgical care for patients with kidney stones.
Official title: Outcomes and Cost-Effectiveness of 6.3French vs. 7.5French Mini-Flexible Ureteroscopy in the Treatment of Renal Stones: A Non-Inferiority, Prospective, Randomized, Single-Blinded Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2026-10-01
Completion Date
2028-08-31
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
6.3Fr Mini-Flexible Ureteroscope
Use of a disposable 6.3Fr mini-flexible ureteroscope during flexible ureteroscopy for renal stone treatment
7.5Fr Mini-Flexible Ureteroscope
Use of a disposable 7.5Fr mini-flexible ureteroscope during flexible ureteroscopy for renal stone treatment
Locations (1)
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada