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

NCT07516106 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-07

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Stone

Interventions

DEVICE

Moses Holmium:YAG laser

Ho:YAG with Moses pulse modulation

DEVICE

Thulium:YAG laser

p-Tm:YAG laser lithotripsy with long pulse mode

Sponsors & Collaborators

Principal Investigators

  • Esteban Emiliani, MD, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-03-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516106 on ClinicalTrials.gov