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Not yet recruitingNCT07639385Updated Jun 30, 2026

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

An interventional study of Dusting and Fragmentation in Thulium Fiber Laser, Fans and Lithotripsy, Laser, sponsored by Bir Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Bir Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 less than 2 cm.

Read the detailed description

Urolithiasis is among the most prevalent urological disorders worldwide, with a lifetime recurrence risk ranging from 30 to 50% in affected individuals. Global Burden of Disease study in 2021 estimated 106 million new incident cases of urolithiasis globally, representing a 47% increase from 1990, driven by population growth, changing dietary patterns, rising rates of metabolic syndrome, and climate-related factors. Regions with tropical and subtropical climates including South Asia bear a disproportionately higher burden, with prevalence estimates of 5-10% compared to 1-5% in temperate regions. Nephrolithiasis is not merely a surgical inconvenience; it imposes significant morbidity through recurrent renal colic, obstructive uropathy, urinary tract infection, and progressive renal dysfunction, with substantial associated healthcare costs.

Retrograde Intra-Renal Surgery (RIRS) has become the preferred minimally invasive modality for the definitive management of most renal calculi endorsed by both the European Association of Urology (EAU) and the American Urological Association (AUA) for stones amenable to endoscopic treatment. It offers the advantage of direct pyelocaliceal access without the morbidity of percutaneous access, with established stone-free rates (SFR) exceeding 90% for stones less than 2 cm in contemporary series.

The operative strategy employed during RIRS specifically, the choice between stone fragmentation and stone dusting remains a subject of active clinical debate, with meaningful implications for operative efficiency, stone-free outcomes, and scope longevity. Fragmentation involves delivering high pulse energy (typically 0.8-1.5 J) at low frequency (5-10 Hz) to reduce calculi into retrievable fragments of less than 4 mm. Dusting employs low pulse energy (0.2-0.5 J) at higher frequency (15-25 Hz) to ablate the stone into sub-millimetre powder particles. In the holmium:YAG (Ho:YAG) laser studies, fragmentation consistently demonstrated superior SFRs. El-Nahas et al. reported a significantly higher SFR with fragmentation compared to dusting (78.6% vs. 58.6%, p=0.035) at 2 months on non-contrast CT, albeit at the cost of a longer operative time (91 vs. 76 minutes, p=0.009). A 2023 systematic review and meta-analysis corroborated these findings, demonstrating that dusting was associated with a lower pooled stone-free rate (OR 0.60; 95% CI 0.41-0.89, p=0.01) and a significantly higher re-treatment rate (OR 2.03; 95% CI 1.31-3.13, p=0.001), though with a shorter operative time and comparable complication profile. These data, however, were generated predominantly with Ho:YAG laser technology and without active suction-assisted clearance, a critical limitation in extrapolating these findings to contemporary practice.

The Thulium Fiber Laser (TFL), introduced into clinical practice in 2018, represents a fundamental technological shift from the Ho:YAG platform. Operating at a wavelength of 1,940 nm, TFL demonstrates a four- to fivefold higher water absorption coefficient, a lower stone ablation threshold, and a more uniform rectangular pulse profile compared to the asymmetrical spike-decay waveform of Ho:YAG. These physical characteristics translate to superior ablation efficiency. TFL achieves fragmentation speeds up to twice and dusting speeds up to ten times faster than Ho:YAG at comparable settings, with significantly less stone retropulsion. Crucially, unlike Ho:YAG where increasing pulse energy generates larger residual fragments, TFL dusting at higher pulse energies does not increase fragment size producing dust particles consistently below 0.254 mm regardless of energy setting, making it inherently better suited to achieving fine, clearable particulate. A systematic review and meta-analysis of TFL-based RIRS reported a pooled SFR of 89.37% (95% CI: 83.93-93.12%), with TFL use independently associated with higher odds of achieving zero-fragment status in multivariable analysis.

The introduction of FANS has fundamentally altered the operative landscape of RIRS by enabling continuous active suction-assisted clearance of ablated stone material in real time. In conventional RIRS without active suction, the inferior stone-free rates historically associated with dusting were largely attributable to inadequate clearance of residual particulate from the pelvicalyceal system. With use of FANS, this limitation is addressed with fragments produced by fragmentation and dust produced by dusting both evacuated under the same negative-pressure suction system. Fragmentation with 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. Given TFL's inherent superiority in generating fine, consistently small dust particles irrespective of pulse energy; 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 any prospective randomised trial. This study is designed to answer that specific question in patients with renal stone less than 2cm, using a rigorously standardised equipment framework, blinded NCCT KUB-based outcome assessment, and a pre-specified non-inferiority margin of 10%.

02

Conditions studied

  • Thulium Fiber Laser
  • Fans
  • Lithotripsy, Laser
  • Renal Stone

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Keywords

  • Dusting
  • Fragmentation
  • Thulium fiber laser
  • FANS
03

In context

Nephrolithiasis

324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.

This study's planned enrollment of 86 is close to the median of 92 across 257 interventional studies indexed under Nephrolithiasis.

Browse Nephrolithiasis studies →

Lead sponsor

Bir Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Renal stone(s) confirmed on non-contrast CT KUB
  • Total stone less than 2cm
  • Stone amenable to flexible ureterorenoscopy (FURS)
  • FANS advanced beyond Pelvi-Ureteric Junction (PUJ)
  • Able and willing to provide written
  • Able to comply with follow-up schedule

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
86 participants (estimated)

Study arms

  • Active comparator
    Fragmentation

    0.8-1J, 5-10Hz

    Procedure: Fragmentation

  • Active comparator
    Dusting

    0.6-0.8J, 12-15Hz

    Procedure: Dusting

Interventions

  • ProcedureDusting

    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.

  • ProcedureFragmentation

    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.

06

What researchers measure

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

  5. Active suction time

    To compare active suction time between fragmentation and dusting

    Time frame: Intra-operative

  6. Number of scope withdrawals

    To compare number of scope withdrawals during active suction between arms

    Time frame: Intra-operative

  7. Re-intervention rates

    To compare need of auxillary procedures to clear residual fragments between two groups

    Time frame: 3 months

  8. Intra-operative Complications

    To compare incidence of bleeding, PCS injury and ureteral injury between 2 groups

    Time frame: Intra-operatively

  9. Post-operative complications

    To compare incidence of fever, UTI, hematuria, urosepsis and ureteric stricture between two groups

    Time frame: at end of surgery up to 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Soto-Palou F, Chen J, Medairos R, Zhong P, Antonelli J, Preminger GM, Lipkin ME. In Pursuit of the Optimal Dusting Settings with the Thulium Fiber Laser: An In Vitro Assessment. J Endourol. 2023 Aug;37(8):914-920. doi: 10.1089/end.2023.0168. Epub 2023 Jun 26. PubMed 37300481 ↗
  • GBD 2021 Urolithiasis Collaborators. The global, regional, and national burden of urolithiasis in 204 countries and territories, 2000-2021: a systematic analysis for the Global Burden of Disease Study 2021. EClinicalMedicine. 2024 Nov 21;78:102924. doi: 10.1016/j.eclinm.2024.102924. eCollection 2024 Dec. PubMed 39640943 ↗
  • El-Nahas AR, Almousawi S, Alqattan Y, Alqadri IM, Al-Shaiji TF, Al-Terki A. Dusting versus fragmentation for renal stones during flexible ureteroscopy. Arab J Urol. 2019 Apr 26;17(2):138-142. doi: 10.1080/2090598X.2019.1601002. eCollection 2019. PubMed 31285926 ↗
  • Almasoud NA, Safar O, Elatreisy A, Alshahrani ST, Libdah SB, Alkhaldi SM, Alsoliman NF, Alderaan AM, Abdel-Al I, Abouelgreed TA, Alabeedi M, Al-Aown A. Super pulsed thulium fiber laser outcomes in retrograde intrarenal surgery for ureteral and renal stones: a systematic review and meta-analysis. BMC Urol. 2023 Nov 7;23(1):179. doi: 10.1186/s12894-023-01355-x. PubMed 37936133 ↗
  • Wen Z, Wang L, Liu Y, Huang J, Chen CX, Wang CJ, Chen LL, Yang XS. A systematic review and meta-analysis of outcomes between dusting and fragmentation in retrograde intrarenal surgery. BMC Urol. 2023 Jul 7;23(1):113. doi: 10.1186/s12894-023-01283-w. PubMed 37420203 ↗
  • Traxer O, Keller EX. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol. 2020 Aug;38(8):1883-1894. doi: 10.1007/s00345-019-02654-5. Epub 2019 Feb 6. PubMed 30729311 ↗
  • Schoenthaler M, Wilhelm K, Kuehhas FE, Farin E, Bach C, Buchholz N, Miernik A. Postureteroscopic lesion scale: a new management modified organ injury scale--evaluation in 435 ureteroscopic patients. J Endourol. 2012 Nov;26(11):1425-30. doi: 10.1089/end.2012.0227. Epub 2012 Aug 27. PubMed 22698147 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07639385
Lead sponsor
Bir Hospital
Responsible party
Akash Chitrakar (Consultant Urologist, Bir Hospital) — Principal investigator
First posted
Jun 10, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 7, 2027 (estimated)
Last update
Jun 30, 2026

Study contacts

Akash Chitrakar, MCh Urology
Contact
dr.akashsurg@gmail.com
+9779849003151

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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