Fragmentation Vs Dusting Using TFL With FANS for Renal Stones up to 500mm3: A Randomized Controll… (NCT07639385) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fragmentation Vs Dusting Using TFL With FANS for Renal Stones up to 500mm3: A Randomized Controlled Study
86 participantsStarted 2026-08-01
Plain-language summary
The use of FANS has changed the operative landscape of RIRS by allowing continuous active suction-assisted clearance of ablated stone material in real time. Use of fragmentation technique in FANS requires high-energy to reduce stone burden into small fragments, followed by active suction of residual fine material. Dusting with FANS, on the other hand, converts the entire stone volume into sub-millimetre particulate that is continuously suctioned away during lasing potentially offering a more streamlined workflow with potentially less energy usage, reduced mechanical stress on the ureteroscope working channel, and fewer scope withdrawals. The combination of TFL dusting with FANS-assisted real-time evacuation may produce stone-free outcomes equivalent or superior to fragmentation, while offering these additional operative efficiencies.
Whether dusting using TFL with FANS is non-inferior or indeed superior to fragmentation using TFL with FANS in terms of stone-free rate at one month has not been evaluated in prospective randomised trial yet. This study aims to answer that specific question in patients with renal stone volume up to 500 mm³.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Renal stone(s) confirmed on non-contrast CT KUB
* Total stone volume \<500 mm³ (calculated using ellipsoid formula: π/6 × L × W × H)
* Stone amenable to flexible ureterorenoscopy (FURS)
* FANS advanced beyond Pelvi-Ureteric Junction (PUJ)
* Able and willing to provide written informed consent
* Able to comply with follow-up schedule
Exclusion Criteria:
* Active urinary tract infection (positive urine culture) at time of planned surgery
* Anatomical anomalies precluding safe FURS (e.g., infundibular stenosis, severe calyceal diverticulum inaccessible to flexible scope)
* Pregnancy or breastfeeding
* Prior ipsilateral renal surgery within 3 months of enrollment
* Concurrent ureteral stone(s) requiring simultaneous treatment
* Renal anomalies: horseshoe kidney, ectopic kidney
* Sheathless procedure
* Unable to comply with follow-up or provide consent
* Participation in another interventional trial within 30 days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.