Recruiting

TFL vs. p-Tm:YAG

Sponsor:

UCLA

Code:

NCT06721975

Conditions

Kidney Stones

Nephrolithiasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thulio pulsed Thulium:YAG (p-Tm:YAG)

Thulium Laser Fiber (TFL)

Study Details

Brief summary:

This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser lithotripsy for kidney stone treatment.

Conditions

Kidney Stones

Nephrolithiasis

Study ID

NCT06721975

Start date

Aug 1, 2024

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required
  • Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines
  • Must be able to give consent
  • Bilateral ureteroscopy will be permitted but only the first side (per surgeon discretion) will be included in the study
  • Surgeons participating in the study must be urological attending surgeons or fellows with subspecialty training in Endourology

Exclusion Criteria:

  • Concomitant stones in the ureter
  • Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
  • Prior radiotherapy to the abdomen or pelvis
  • Neurogenic bladder or spinal cord injury
  • Pregnancy
  • Untreated UTI

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: p-Tm:YAG laser system

This is a new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG)

active comparator: TFL laser system

The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure.

Interventions

Thulio pulsed Thulium:YAG (p-Tm:YAG)

A new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG ) is beginning to be studied in vitro and in vivo. Dornier Thulio p-Tm:YAG may represent an attractive new laser platform, with comparable properties to TFL including decreased retropulsion, smaller dust, and improved ablation efficiency relative to Ho:YAG.

Thulium Laser Fiber (TFL)

The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure

Primary outcome measure

  • The amount of energy used per given stone volume [ Time Frame: From enrollment to the follow up imaging at 6-12 weeks ]

Central Contacts and Locations

Central contacts

Jade McDermott, BS

858-777-9721j3mcdermott@health.ucsd.edu

Roger L Sur, MD

(858) 657-7876rlsur@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92122

Contacts

Jamie L Finegan, BA

858-777-9721jlfinegan@health.ucsd.edu

Roger L Sur, MD

(858) 657-7876rlsur@health.ucsd.edu

Principal Investigator:

Roger L Sur, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 9, 2026

Last verified

Aug, 2025

Keywords

  • laser lithotripsy
  • laser
  • nephrolithiasis
  • kidney stone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-07-09.