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RecruitingNCT06306222Updated Mar 12, 2024

Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease

An interventional study of Laser lithotripsy in Kidney Stone and Ureteral Stone, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.

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Conditions studied

  • Kidney Stone
  • Ureteral Stone
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In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's planned enrollment of 120 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 99 Years
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

  • Renal/ureteral stones > 4 mm

Exclusion criteria

Exclusion Criteria:

  • Anatomical abnormalities
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Thulium fiber laser (TFL) lithotripsy

    Lithotripsy with TFL is a recently introduced procedure, that will be tested in this study.

    Device: Laser lithotripsy

  • Active comparator
    Holmium:YAG laser lithotripsy

    Holmium:YAG laser lithotripsy represents the gold standard for this procedure since 30 years.

    Device: Laser lithotripsy

Interventions

  • DeviceLaser lithotripsy

    Ureteroscopic laser lithotripsy

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What researchers measure

Primary outcomes

  1. Lithotripsy speed

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Stone free rate

    Time frame: 3 months after the procedure

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06306222
Lead sponsor
IRCCS San Raffaele
Responsible party
Eugenio Ventimiglia (Principal investigator, IRCCS San Raffaele) — Principal investigator
First posted
Mar 12, 2024
Start date
Nov 23, 2023
Primary completion
Nov 23, 2025 (estimated)
Completion
Feb 23, 2026 (estimated)
Last update
Mar 12, 2024

Study contacts

D'Arma Alessia
Contact
darma.alessia@hsr.it
+390226435506

Oversight

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

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