Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With FANS Access Sheaths

ConditionKidney Stone
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

The purpose of this study is to compare two laser technologies that are routinely used during ureteroscopy for the treatment of kidney stones. Specifically, this study will compare a pulsed Thulium:YAG laser to a pulse-modulated Holmium:YAG laser (Moses technology) to evaluate how effective and safe they are when used to break kidney stones.

Primary endpoints include stone-free rate and the zero stone-free rate at a standardized postoperative. Secondary endpoints include total operative time, lasing time (s), laser energy expended (J), efficiency (laser energy expended/stone volume; stone volume/lasing time). These endpoints aim to provide a comprehensive assessment of the clinical effectiveness and procedural efficiency of the two laser systems.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 18 years or older

Must be able to give consent

Disqualifiers

Concomitant stones in the ureter

Prior radiotherapy to the abdomen or pelvis

Neurogenic bladder or spinal cord injury

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Moses Holmium:YAG laser

    Device

    Ho:YAG with Moses pulse modulation

  • Thulium:YAG laser

    Device

    p-Tm:YAG laser lithotripsy with long pulse mode

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Pulsed Thulium:YAG laserExperimental treatment 1 intervention
Group B: Pulse-modulated Holmium:YAG laserExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Stone-free rate (absence of any fragments ≥ 2mm)

Time frame
Month 1
2

Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month)

Time frame
Month 1

Secondary outcomes

1

Total operative time

Time frame
From first insertion of instruments to final removal of all instruments (up to 3 hours)
2

Lasing time

Time frame
From start of lasing to end of lasing (up to 1 hour)
3

Laser energy expended (J)

Time frame
From start of lasing to end of lasing (up to 1 hour)
4

Laser energy expended per stone volume

Time frame
From start of lasing to end of lasing (up to 1 hour)

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: