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Kidney CalculiNCT03995758

MOSES Lithotripsy Technology Applied to Stone Fragmentation During Ureteroscopy

A study testing MOSES in people with Kidney Calculi, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To determine if the effects of MOSES laser modulation technology can improve the safety and efficiency to laser fragmentation resulting in decreased total laser time, reduced potential for injury to the patient, and total OR time and utilization. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Calculi
What is being tested?
MOSES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteUnited States
Study dates
6 Jun 2019to 11 Jun 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years of age
  • Kidney or ureteral stone requiring laser lithotripsy fragmentation

Who cannot join

  • < 18 years of age
  • Infectious, struvite stones.
  • Atypical collecting system anatomy that prolongs the case (ureteral stricture, malrotated kidney, infundibular stenosis, ureteral duplication)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University Health Physicians Urology

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

To determine if the effects of MOSES laser modulation technology can improve the safety and efficiency to laser fragmentation resulting in decreased total laser time, reduced potential for injury to the patient, and total OR time and utilization.

Read the detailed description

MOSES technology was developed by Lumenis Ltd to maximize the lithotripsy potential of high powered lasers. Typically, a holmium laser unit is used to treat kidney a ureteral stones that are too large to remove en block. Laser lithotripsy allows for a large stone to be partitioned into smaller fragments that can be removed with an endoscopic basket device. Holmium technology has existed for more than 20 years, however, low total power (40 watt) and minimal modulations (Joules and Hertz) of the laser energy by the laser units limited the capacity to improve lithotripsy efficiency.

With the advent of high power (120 watt) lasers with 4 laser cores and developments in software to modulate the laser energy, many more options have emerged for laser lithotripsy of kidney and ureteral stones. At Indiana University Health Physicians Urology, the laser units used for nephrolithotripsy are engineered and produced by Lumenis Ltd. These units are fitted with MOSES technology. Standard laser lithotripsy or MOSES laser lithotripsy can be performed using the same unit and during the same case by simple turning MOSES on or off on the laser touch screen (image 1). MOSES is propriety technology that is software based modulation of the laser energy delivered from the holmium::yag laser source. The software changes the pulsed laser to have two peaks of energy - one to displace the water in front of the stone and the second to deliver the laser energy to the stone. Holmium laser energy dissipates quickly in water, so the displacement of water in front of the stone means more energy is delivered to the stone. With more energy delivery, stone fragmentation is expected to occur more rapidly.

When treating kidney or ureteral stones, there are two distinct surgical approaches. One technique is to use laser lithotripsy to break a stone into tiny pieces called dusting. Dusting technique attempts to turn a stone into a slurry of 2mm or less stone fragments that the patient can pass spontaneously. There are some urologist who promote the use of MOSES technology to improve the efficiency of the dusting technique and reduce operative time. Another approach to endoscopic stone surgery is to laser the stone into fragments to remove with a basket. There is far less laser energy used in this process, however, hard stones and larger stones can take time to fragment. Based on the dusting ureteroscopy data, MOSES technology could still improve fragmentation efficiency and reduce overall operative time.

This is a blinded study. The research coordinator will present to the OR prior to the surgeon to meet with OR staff. At this time, the coordinator will inform the OR staff which group the participant has been randomly assigned. OR staff will be educated to set the laser as instructed by the surgeon but not share whether the MOSES laser lithotripsy is being used. Surgeons will not be aware of the group assignment. The surgeons are only able to adjust the laser energy settings between 0.4-1.0 joules and 4-15 hertz. To control for stone fragment size, surgeons will have to use an 13 french ureteral access sheath independent of ureteral diameter. The MOSES setting is turned on with a touch pad attached to the laser unit. Once the surgeon is ready to laser fragment the stone, the laser will be activated and with the surgeon provided laser energy settings. The laser technician/nurse will follow randomization and add or remove the MOSES option. The surgeons will not be informed if using standard laser or MOSES augmented laser technology. At the conclusion of laser fragmentation, stone basket extraction will occur and once all fragments are removed, the patient will have a ureteral stent placed, awoken, extubated and transferred to the post anesthesia recovery unit. Objective data about laser settings, utilization time and total energy will be obtained at the conclusion of the case. Additionally, the circulating team will record the total OR time. Other variables of interest include blood loss, blood transfusion requirements and complications (utilizing Clavien-Dindo classification) with an expected rate of approximately 1-2%. Subjective grading of stone movement during laser fragmentation as well as stone migration will be recorded.

In addition to the intraoperative variables mentioned above, clinical information including stone size, location, and stone analysis will be recorded.

Conditions
Kidney Calculi
Being tested
MOSES
Medical subject headings
Kidney Calculi

What participants receive

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

  • MOSESDevice

    software based modulation of the laser energy delivered from the homium laser source. The software changes the pulsed laser to have two peaks of energy - one to displace water in front of the stone and a second to deliver the laser energy to the stone

Study groups in NCT03995758
Study groupRoleWhat they receive
Standard laser lithotripsyActive comparatorstandard of care for stone fragmentation in ureteroscopy
Receives: Device: MOSES
MOSES laser lithotripsyActive comparatorMOSES technology used for stone fragmentation in ureteroscopy
Receives: Device: MOSES

What is being measured

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

  1. The Primary Endpoint of Interest Will be Reduction in Mean Total OR Time

    To determine the effects of MOSES laser modulation technology can improve the safety and efficiency to laser fragmentation resulting in decreased total laser time, reduced potential for injury to the patient, and total OR time and utilization.

    Measured: Postoperative day 1

Secondary outcomes (1)
  1. Number of Participants With Complications

    Clavien Classification of Surgical Complications:

    Grade I: Any deviation from the normal post-operative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.

    Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at bedside.

    Grade II: Requiring pharmacological treatment with drugs other than such allowed for Grade I complications. Blood transfusions and total parenteral nutrition are also included.

    Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication (including CNS complications) requiring IC/ICU management.

    Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multi-organ dysfunction Grade V: Death of a patient

    Measured: 30 days

Timeline

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

  1. First posted24 Jun 2019
  2. Study start6 Jun 2019
  3. Primary completion13 May 2021
  4. Study completion11 Jun 2021

Why it stopped: Original study PI departed the institution

Resources

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
The patients will be randomized 1:1 to either standard laser lithotripsy or MOSES laser lithotripsy.
Masking
Single blind
Who is masked
Investigator
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03995758
Sponsor's protocol ID
1901990102
Status last verified
Jun 2025
First submitted
20 Jun 2019
Last updated
4 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MOSES in people with Kidney Calculi, run by Indiana University at 1 site 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 3 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: stopped early, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 Jul 2025). 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?

The Primary Endpoint of Interest Will be Reduction in Mean Total OR Time (time frame: Postoperative day 1). 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 4 Jul 2025.

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