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NCT Number: NCT07153978

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

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.

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Key information

Conditions

Renal Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Retrograde Intrarenal Surgery Thulium Fiber Laser Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Gaziantep

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effectivity of TFL on large renal stone

Device

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.

Primary outcomes

  1. The primary outcome was to assess the effectiveness of the laser.

    Time frame: 12 months

    Fragmentation success was used to evaluate the laser effectiveness of laser.

Secondary outcomes

  1. The secondary outcome was the evaluation of factors affecting stone-free rates

    Time frame: 3 months

    A residual fragment of ≤2 mm was considered stone-free. The unit of measure for all parameters was the percentage of patients stone-free.

Sponsors and collaborators

Lead sponsor

Muharrem Baturu

Other

Collaborators

  • University of Gaziantep

Registry information

Official study title

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

Acronym: RIRS and TFL

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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