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

ConditionsKidney StonesNephrolithiasisRenal Calculi
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSault Area Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled to undergo flexible ureteroscopy for renal stones.

Renal stone size ≤15 mm in the greatest dimension.

No indwelling ureteral stent at the time of surgery.

Able and willing to provide written informed consent.

Disqualifiers

Anatomical abnormalities of the urinary tract (e.g., ureteral stricture, horseshoe kidney, ectopic kidney).

Solitary kidney.

Pregnancy.

Stones located within a calyceal diverticulum.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 6.3Fr Mini-Flexible Ureteroscope

    Device

    Use of a disposable 6.3Fr mini-flexible ureteroscope during flexible ureteroscopy for renal stone treatment

  • 7.5Fr Mini-Flexible Ureteroscope

    Device

    Use of a disposable 7.5Fr mini-flexible ureteroscope during flexible ureteroscopy for renal stone treatment

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: 6.3Fr Mini-Flexible UreteroscopeExperimental treatment 1 intervention
Group B: 7.5Fr Mini-Flexible UreteroscopeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone Free Rate

Stone-free status defined as the absence of residual stone fragments greater than 2 mm on non-contrast CT KUB

Time frame
1 month after surgery
2

Primary Renal Access Success Rate

Successful passage of the flexible ureteroscope into the renal collecting system without the need for preoperative ureteral stenting

Time frame
Perioperative/Periprocedural

Secondary outcomes

1

Operative Time

Total operative time measured from insertion of the ureteroscope until completion of the procedure

Time frame
During surgery
2

Intraoperative Fluoroscopy Use

Fluoroscopy utilization during the procedure, including fluoroscopy time

Time frame
During surgery
3

Intraoperative Ureteral Trauma as Assessed by the Traxer Ureteral Injury Scale

Ureteral trauma will be assessed using the Traxer Ureteral Injury Scale, graded from 0 to 3, where Grade 0 indicates no observable ureteral injury and Grade 3 indicates the most severe ureteral injury. Higher scores indicate greater severity of ureteral injury.

Time frame
Perioperative/Periprocedural
4

Postoperative Ureteral Stenting Rate

Percentage of participants requiring ureteral stent placement at the end of surgery

Time frame
Immediately after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sault Area Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: