6.3Fr Versus 7.5Fr Mini-Flexible Ureteroscopy for Renal Stones (MINI-FURS)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Stone Free Rate — 1 month after surgery
  Stone-free status defined as the absence of residual stone fragments greater than 2 mm on non-contrast CT KUB
• Primary Renal Access Success Rate — Perioperative/Periprocedural
  Successful passage of the flexible ureteroscope into the renal collecting system without the need for preoperative ureteral stenting

Trial sites (1)

Other trials for the same condition