An interventional study of Effectivity of TFL on large renal stone in Renal Stones, Retrograde Intrarenal Surgery and Thulium Fiber Laser, sponsored by Muharrem Baturu. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Muharrem Baturu · Not applicable, Interventional, and Diagnostic
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.
460 studies on the registry are indexed under Nephrolithiasis; 108 are open to participants now.
This study's enrollment of 81 is below the median of 92 across 361 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Muharrem Baturu is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Demographic data (age, gender, body mass index (BMI)), stone characteristics (size, location, Hounsfield Unit (HU) value) and durations of the procedures were recorded. Patients over 18 years of age, with kidney stones larger than 1000 mm³, single or multiple stones and those eligible for RIRS were included in the study. Patients under 18 years of age, those with bleeding diathesis or inability to discontinue anticoagulant/antiaggregant therapy, cases with a history of previous RIRS, individuals who did not attend follow-up visits, patients in whom postoperative residual stone assessment could not be made, or had concomitant bladder or ureteral stones were excluded. SFRs, the need for a second session of RIRS and complications were noted. General anesthesia was used. Rigid ureteroscope was inserted through urethral meatus. 11/13 F ureteral sheath was advanced over guidewire under fluoroscopy. Laser settings varied 0.2J/100Hz to 1J/10Hz based on stone fragility.
Device: Effectivity 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.
The primary outcome was to assess the effectiveness of the laser.
Fragmentation success was used to evaluate the laser effectiveness of laser.
Time frame: 12 months
The secondary outcome was the evaluation of factors affecting stone-free rates
A residual fragment of ≤2 mm was considered stone-free. The unit of measure for all parameters was the percentage of patients stone-free.
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Muharrem Baturu