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

Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With Flexible And Navigable Ureteric Access Sheath (FANS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Stone
• Intervention / Treatment: Device: Thulium:YAG laser; Device: Moses Holmium:YAG laser

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esteban Emiliani, MD, PhD; Phone Number: 646-290-4549; Email: esteban.emilianisanz@nyulangone.org
• Study Contact Backup: Name: Rozalba Gogaj, MD, MPH; Phone Number: 646-825-5663; Email: Rozalba.gogaj@nyulangone.org

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 18 years or older
• Must be able to give consent
• Bilateral ureteroscopy will be permitted , but only the side(s) where the FANS access sheath was used (per surgeon discretion) will be included in the study, however can include both sides as separate units. Subjects will be enrolled only once in the study. No subject will be enrolled more than a single time. For patients undergoing bilateral ureteroscopy, each kidney will be considered a separate unit for stone-related assessments. Peri-patient measures, such as operative time, will be recorded at the patient level. Bilateral cases will be clearly identified and handled consistently to ensure accurate and appropriate interpretation of study outcomes.
• Must be a patient of one of the surgeons participating in this study.

Exclusion Criteria:

• Concomitant stones in the ureter
• Prior radiotherapy to the abdomen or pelvis
• Neurogenic bladder or spinal cord injury
• Pregnancy
• Untreated urinary tract infection (UTI)
• Anatomical abnormalities (including, but not limited to, bifid system, pelvic kidney, horseshoe kidney)
• Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed Thulium:YAG laser; Flexible Ureterorenoscopy (URS) for kidney stone treatment will be performed per standard medical care, and surgeons will use the Pulsed Thulium:YAG laser during the procedure.	Device: Thulium:YAG laser; p-Tm:YAG laser lithotripsy with long pulse mode; Other Names: Thulio
Experimental: Pulse-modulated Holmium:YAG laser; Flexible Ureterorenoscopy (URS) will be performed using standard techniques without deviation from routine care, and surgeons will use the pulse-modulated Holmium:YAG laser during the procedure.	Device: Moses Holmium:YAG laser; Ho:YAG with Moses pulse modulation; Other Names: MOSES 2.0 Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Stone-free rate (absence of any fragments ≥ 2mm)	Month 1
Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month)	Month 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Total operative time	From first insertion of instruments to final removal of all instruments (up to 3 hours)
Lasing time	From start of lasing to end of lasing (up to 1 hour)
Laser energy expended (J)	From start of lasing to end of lasing (up to 1 hour)
Laser energy expended per stone volume	From start of lasing to end of lasing (up to 1 hour)
Stone volume per lasing time	From start of lasing to end of lasing (up to 1 hour)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Esteban Emiliani, MD, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Nephrolithiasis; Pathological Conditions, Signs and Symptoms; Kidney Calculi
• Other Study ID Numbers: 25-01646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared to achieve aims in the approved proposal beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting researcher provide a methodologically sound proposal and executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: esteban.emilianisanz@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal will be granted access to achieve aims in the approved proposal. Requests should be directed to esteban.emilianisanz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes