Clinical Trials Directory

Trials / Completed

CompletedNCT07153978

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
Phase
N/A
Study type
Interventional
Enrollment
81 (actual)
Sponsor
Muharrem Baturu · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEffectivity of TFL on large renal stoneWhile 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.

Timeline

Start date
2023-11-01
Primary completion
2024-12-01
Completion
2025-06-01
First posted
2025-09-04
Last updated
2025-09-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07153978. Inclusion in this directory is not an endorsement.