Health TrialsbyHealthPanel

Fragmentation Vs Dusting With FANS for Renal Stones Less Than 2cm: A Randomized Controlled Study

ConditionsThulium Fiber LaserFansLithotripsy, LaserRenal Stone
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBir Hospital

About this trial

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 less than 2 cm.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Renal stone(s) confirmed on non-contrast CT KUB

Total stone less than 2cm

Stone amenable to flexible ureterorenoscopy (FURS)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dusting

    Procedure/Surgery

    Dusting employs low pulse energy (0.6-0.8 J) at higher frequency (12-15 Hz) to ablate the stone into sub-millimetre powder particles.

  • Fragmentation

    Procedure/Surgery

    Fragmentation involves delivering high pulse energy (typically 0.6-0.8 J) at low frequency (5-10 Hz) to reduce calculi into retrievable fragments of less than 4 mm.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: FragmentationActive comparator 1 intervention
Group B: DustingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone free rate

To determine whether dusting is non-inferior to fragmentation using Thulium Fiber Laser (TFL) with Flexible and Navigable Ureteral Access Sheath (FANS) with respect to stone-free rate (SFR) at 1 month post-procedure in patients with renal stones less than 2cm.

Time frame
At 1 month after surgery

Secondary outcomes

1

Operative time

To compare total operative time between fragmentation and dusting arms

Time frame
Intra-operative
2

Lasing time

To compare laser activation time between fragmentation and dusting

Time frame
Intra-operative
3

Energy consumption

To compare Energy consumption between two arms

Time frame
Intra-operative
4

Ablation speed

To compare ablation speed between two arms

Time frame
Intra-operative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Bir Hospital

Lead sponsor

Source ClinicalTrials.gov

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