Kidney StoneNCT07516106
Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With FANS Access Sheaths
A study testing Moses Holmium:YAG laser and Thulium:YAG laser in people with Kidney Stone, run by NYU Langone Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Moses Holmium:YAG laser and Thulium:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
NYU Langone Health
New York, New York, 10016
Mayo Clinic Arizona
Phoenix, Arizona, 85054
About this study
Official title: 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.
- Conditions
- Kidney Stone
- Being tested
- Moses Holmium:YAG laser, Thulium:YAG laser
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moses Holmium:YAG laserDevice
Also called MOSES 2.0 Technology
Ho:YAG with Moses pulse modulation
Thulium:YAG laserDevice
Also called Thulio
p-Tm:YAG laser lithotripsy with long pulse mode
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Thulium:YAG laser | Experimental | 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. Receives: Device: Thulium:YAG laser |
| Pulse-modulated Holmium:YAG laser | Experimental | 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. Receives: Device: Moses Holmium:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate (absence of any fragments ≥ 2mm)
Measured: Month 1
Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month)
Measured: Month 1
Secondary outcomes (5)
Total operative time
Measured: From first insertion of instruments to final removal of all instruments (up to 3 hours)
Lasing time
Measured: From start of lasing to end of lasing (up to 1 hour)
Laser energy expended (J)
Measured: From start of lasing to end of lasing (up to 1 hour)
Laser energy expended per stone volume
Measured: From start of lasing to end of lasing (up to 1 hour)
Stone volume per lasing time
Measured: From start of lasing to end of lasing (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startJun 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A simple randomization scheme will be used to assign a laser to each case according to a predefined allocation scheme. Randomization will be conducted prior to surgery, and allocation will be concealed until the start of the operating room workflow.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esteban Emiliani, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516106
- Sponsor's protocol ID
- 25-01646
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07516106
- Acronym / sponsor ID
- 25-01646
- Conditions
- Kidney Stone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A simple randomization scheme will be used to assign a laser to each case according to a predefined allocation scheme. Randomization will be conducted prior to surgery, and allocation will be concealed until the start of the operating room workflow.
| Arm | Type | Receives |
|---|---|---|
| Pulsed Thulium:YAG laser | Experimental | Device: Thulium:YAG laserFlexible 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. |
| Pulse-modulated Holmium:YAG laser | Experimental | Device: Moses Holmium:YAG laserFlexible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Concomitant stones in the ureter
- Prior radiotherapy to the abdomen or pelvis
- Neurogenic bladder or spinal cord injury
- Pregnancy
- Untreated urinary tract infection (UTI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moses Holmium:YAG laserAlso: MOSES 2.0 TechnologyHo:YAG with Moses pulse modulation | Device | Pulse-modulated Holmium:YAG laser |
| Thulium:YAG laserAlso: Thuliop-Tm:YAG laser lithotripsy with long pulse mode | Device | Pulsed Thulium:YAG laser |
Primary outcome
Stone-free rate (absence of any fragments ≥ 2mm)
Time frame: Month 1
Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month)
Time frame: Month 1
5 secondary outcomes
Total operative time
Time frame: From first insertion of instruments to final removal of all instruments (up to 3 hours)
Lasing time
Time frame: From start of lasing to end of lasing (up to 1 hour)
Laser energy expended (J)
Time frame: From start of lasing to end of lasing (up to 1 hour)
Laser energy expended per stone volume
Time frame: From start of lasing to end of lasing (up to 1 hour)
Stone volume per lasing time
Time frame: From start of lasing to end of lasing (up to 1 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esteban Emiliani, MD, PhD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moses Holmium:YAG laser and Thulium:YAG laser in people with Kidney Stone, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esteban Emiliani, MD, PhD (646-290-4549, esteban.emilianisanz@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (absence of any fragments ≥ 2mm) (time frame: Month 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.