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Safety of Thulium Fiber Laser Litothripsy in the Management of Large Renal Stones (>1000 mm³) and Factors Affecting Treatment Success

Safety of Thulium Fiber Laser Litothripsy in the Management of Large Renal Stones (>1000 mm³) and Factors Affecting Treatment Success:

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07153978
Acronym
RIRS and TFL
Enrollment
81
Registered
2025-09-04
Start date
2023-11-01
Completion date
2025-06-01
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stones, Retrograde Intrarenal Surgery, Thulium Fiber Laser

Keywords

Retrograde intrarenal surgery,, Thulium fiber laser, Stone free rate, Kidney stone, Hounsfield Unit.

Brief summary

The aim of this study is to compare the efficacy and safety of Thulium Fiber Laser (TFL) litothripsy according to stone density and the factors affecting success in patients undergoing retrograde intrarenal surgery (RIRS) for renal calculi \>1000 mm3. Between November 2023 and December 2024, 81 patients with a stone volume \>1000 mm3 who underwent RIRS with TFL in our clinic were prospectively and sequentially evaluated. Stone density of the patients was measured, and expressed in Hounsfield Units (HU). Patients with stone densities \<1000 HU and ≥1000 HU were categorized as Groups 1, and 2, respectively. Demographic data, data of intraoperative laser use, stone-free rates (SFRs), the need for a second session of RIRS and complications were recorded. Duration of TFL litothripsy, total energy used, laser ablation speed (mm3/sec), laser ablation efficiency (mm3/J) and laser energy consumption (J/mm3) were calculated. Correlation tests, univariate and multivariate logistic regression tests were used for statistical analysis.

Interventions

DEVICEEffectivity of TFL on large renal stone

While literature studies on TFL have focused on the effect of stone size on laser efficacy parameters, the present study is important as it is a prospective study examining the effects of TFL lithotripsy on SFRs in stones \>1000 mm3.

Sponsors

University of Gaziantep
CollaboratorOTHER
Muharrem Baturu
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients ≥18 years of age * Presence of kidney stones larger than 1000 mm³ * Patients with single or multiple kidney stones * Patients eligible for retrograde intrarenal surgery (RIRS)

Exclusion criteria

* Patients younger than 18 years * Pregnant or breastfeeding women * Patients with uncorrected coagulopathy * Patients with active urinary tract infection * Patients with severe anatomic abnormalities preventing RIRS * Patients unwilling or unable to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome was to assess the effectiveness of the laser.12 monthsFragmentation success was used to evaluate the laser effectiveness of laser.

Secondary

MeasureTime frameDescription
The secondary outcome was the evaluation of factors affecting stone-free rates3 monthsA residual fragment of ≤2 mm was considered stone-free. The unit of measure for all parameters was the percentage of patients stone-free.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026