Renal StoneNCT06070714

Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones

A study testing Holmium laser with pulse modulation and Thulium fiber laser in people with Renal Stone, run by University of Wisconsin, Madison at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective randomized controlled trial designed to assess the efficacy and safety of Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser (thulium fiber laser), in dusting of renal… Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Renal Stone
What is being tested?: Holmium laser with pulse modulation and Thulium fiber laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 178 participants
Where: 4 sitesUnited States
Study dates: 7 Sep 2023to 31 Oct 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with renal stones who require endoscopic laser treatment in the outpatient operating room. Patients may have an ureteropelvic junction (UPJ) stone if the treatment of the stone is completed in the kidney.
Patients' stone size in a single renal unit of greater than or equal to 5 millimeters (mm) and less than or equal to 20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT as assessed by the urologist. Patients with multiple stones will be included as long as their largest stone size falls within the above parameters.

Who cannot join

Pregnant patients
Patients with transplant kidneys or other anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture
Patients with irreversible coagulopathy
Patients with known ureteral stricture disease
Patient who do not have a pre-operative CT
Non-English speaking patients and patients in other vulnerable groups such as lacking of decision-making capability, prisoner, or adult unable to consent

Show all 11Show fewer

Uric acid composition greater than 50 percent on pre operative stone analysis. Patients will be excluded post operatively if stone analysis from the time of surgery is greater than 50 percent uric acid.
Prior ureteroscopy within 6 weeks of current surgery
Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope
Patients with only ureteral stones (ureteropelvic junction stones may be included as long as treated in the kidney)
Patients with renal tubular acidosis or medullary sponge kidney

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Glickman Urological & Kidney Institute
Cleveland, Ohio, 44125
University of California - Los Angeles
Los Angeles, California, 90095
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 57392
Mount Sinai Health System
New York, New York, 10029

Other trials in United States

About this study

Official title: Multi-Center Randomized Clinical Trial Evaluating the Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones

Read the detailed description

This study will be a randomized clinical trial comparing ureteroscopy with laser lithotripsy with the Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser technology (thulium fiber laser).

The primary objective is to compare the stone free rate as determined by computed tomography (CT) scan at two months (6-10 weeks) post operatively. A single urologist will evaluate all CT scans for residual stones and will be blinded to which laser was used during ureteroscopy.

The following information will be collected for research purposes as secondary outcomes: (1) stone treatment time (time from the start of lasing to the end of lasing; minutes); (2) total operative time (minutes); (3) lasing time (minutes, time the laser was in use, not including pedal pauses); (4) total energy used (kilojoules, kJ); (5) laser efficiency (mm per minute); (6) number of times the laser pedals are pressed (left, right, and total pedal presses); (7) laser fiber size; (8) stone analysis; (9) complications, and (10) patients' quality of life.

The results from the pre- and post-operative quality of life survey (WISQOL short form) will be obtained from the patient's medical record. A total of 3 clinic visits (i.e., the pre-operative visit and the stone surgery, one post-operative visit after 2 months of the surgery) will be needed for this study.

All visits are standard of care. Stone parameters (i.e. size, location, Hounsfield units, presence of hydronephrosis, stone volume, and composition), demographic information, co-morbidities, and post-operative parameters will be collected from the medical record in HealthLink.

The Thulium laser company is not involved in this research.

Conditions: Renal Stone
Being tested: Holmium laser with pulse modulation, Thulium fiber laser
Medical subject headings: Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Holmium laser with pulse modulationDevice
The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.
Thulium fiber laserDevice
The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.

Study groups in NCT06070714
Study group	Role	What they receive
Holmium laser with pulse modulation	Active comparator	Not described Receives: Device: Holmium laser with pulse modulation
Thulium fiber laser	Active comparator	Not described Receives: Device: Thulium fiber laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Stone Free Rate
The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser.
Measured: Post-operative (up to 10 weeks)

Secondary outcomes (6)

Stone Treatment Time in Minutes
Time from the start of lasing to the end of lasing.
Measured: day of procedure (up to 3 hours)
Procedural Time
Time from the insert to removal of the instrument.
Measured: day of procedure (up to 3 hours)
Total Energy Used in Kilojoules
The total energy used for the stone surgery is documented by the laser machine. With reported case averages ranging from 0.1 to 42.1 kJ depending on stone size and technique (e.g., dusting vs. fragmentation).This parameter is a measure of the efficiency of stone treatment.
Measured: day of procedure (up to 3 hours)
Number of Participants With Complications
All complications are documented during the procedure and the total follow-up time (up to 10 weeks). This outcome measure include the procedural complications and post-operative complications.
Measured: day of procedure (up to 10 weeks)
Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment
WISQOL short form is a 6 item questionnaire which can be scored from 1(worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes.
Measured: before the procedure (up to 3 hours before procedures)
Participant Quality of Life as Measured by the WISQOL Short Form Score Post-procedure Assessment
WISQOL short form is a 6 item questionnaire which can be scored from 1 (worst outcome) to 5 (best outcome). The raw score range is 6-30. In the study, standardized total score is used. The range of the standardized total score is 0-100 with higher scores meaning better outcomes.
Measured: Post-operative (up to 10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 202331 Oct 2025

First posted6 Oct 2023
Study start7 Sep 2023
Primary completion31 Oct 2025
Study completion31 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal StoneStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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: Participants will be randomized (ratio 1:1) to be treated with either the holmium laser with pulse modulation or the thulium fiber laser. Each site will randomize their own participants. Block randomization in block sizes of 4 will be used to assign participants to each laser treatment group. If unable to use the specified laser for any reason, the participant will be considered a withdrawal
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06070714
Sponsor's protocol ID: 2023-0932
Other IDs: Urology, Protocol Version 5/21/24
Status last verified: Feb 2026
First submitted: 2 Oct 2023
Last updated: 27 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center Randomized Clinical Trial Evaluating the Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones
ClinicalTrials.gov ID: NCT06070714
Acronym / sponsor ID: 2023-0932
Conditions: Renal Stone
Study type: Interventional
Recruitment status: Completed
Enrolment: 178 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 7 Sep 2023 (actual)
Primary completion: 31 Oct 2025 (actual)
Study completion: 31 Oct 2025 (actual)
First posted: 6 Oct 2023 (actual)
Results: Posted 27 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The Thulium laser company is not involved in this research.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized (ratio 1:1) to be treated with either the holmium laser with pulse modulation or the thulium fiber laser. Each site will randomize their own participants. Block randomization in block sizes of 4 will be used to assign participants to each laser treatment group. If unable to use the specified laser for any reason, the participant will be considered a withdrawal

Arm	Type	Receives
Holmium laser with pulse modulation	Active comparator	Device: Holmium laser with pulse modulation
Thulium fiber laser	Active comparator	Device: Thulium fiber laser

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with renal stones who require endoscopic laser treatment in the outpatient operating room. Patients may have an ureteropelvic junction (UPJ) stone if the treatment of the stone is completed in the kidney.
Patients' stone size in a single renal unit of greater than or equal to 5 millimeters (mm) and less than or equal to 20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT as assessed by the urologist. Patients with multiple stones will be included as long as their largest stone size falls within the above parameters.

Key exclusion criteria (11 listed)

Pregnant patients
Patients with transplant kidneys or other anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture
Patients with irreversible coagulopathy
Patients with known ureteral stricture disease
Patient who do not have a pre-operative CT

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
Holmium laser with pulse modulationThe holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.	Device	Holmium laser with pulse modulation
Thulium fiber laserThe thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.	Device	Thulium fiber laser

Primary outcome

Stone Free Rate
Time frame: Post-operative (up to 10 weeks)
The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser.

6 secondary outcomes

Stone Treatment Time in Minutes
Time frame: day of procedure (up to 3 hours)
Procedural Time
Time frame: day of procedure (up to 3 hours)
Total Energy Used in Kilojoules
Time frame: day of procedure (up to 3 hours)
Number of Participants With Complications
Time frame: day of procedure (up to 10 weeks)
Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment
Time frame: before the procedure (up to 3 hours before procedures)
Participant Quality of Life as Measured by the WISQOL Short Form Score Post-procedure Assessment
Time frame: Post-operative (up to 10 weeks)

Results and safety

Results posted to the registry on 27 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Holmium Laser With Pulse Modulation	89	68
Thulium Fiber Laser	89	65

Primary outcome: Stone Free Rate

Time frame: Post-operative (up to 10 weeks). Count of participants. Unit: Participants

Measure	Holmium Laser With Pulse Modulation n = 68	Thulium Fiber Laser n = 65
Value	36	34

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From stone surgery to 10 week post operative follow up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Holmium Laser With Pulse Modulation	0 of 89 (0%)	0 of 89 (0%)	0 of 89
Thulium Fiber Laser	0 of 89 (0%)	0 of 89 (0%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Stephen Nakada, MD, FACS, FRCS principal investigator

University of Wisconsin, Madison

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Holmium laser with pulse modulation and Thulium fiber laser in people with Renal Stone, run by University of Wisconsin, Madison at 4 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone Free Rate (time frame: Post-operative (up to 10 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06070714.

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 27 Feb 2026.