MOSES Lithotripsy Technology Applied to Stone Fragmentation During Ureteroscopy
Phase: NA
Conditions: Kidney Calculi
Sponsor: Indiana University

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MOSES Lithotripsy Technology Applied to Stone Fragmentation during 
Ureteroscopy.  
 
 
Principal Investigator:  Marcelino Rivera, MD  
IU Health Physicians Urology 
1801 N Senate Blvd 
Suite 220 
Indianapolis, IN 46202 
 
 
 
 
 
 
 
 
 
 
 
Co-Investigators:   
Tim Large MD 
Deepak Agarwal, MD 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 
 

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1.0 
Background 
 
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 our institution, 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, we would expect stone fragmentation 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. We feel, based on 
the dusting ureteroscopy data, that MOSES technology could still improve fragmentation 
efficiency and reduce overall operative time.  
 
2.0 
Rationale and Specific Aims 
 
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.  
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion criteria: 
• 
>18 years of age 
• 
Kidney or ureteral stone requiring laser lithotripsy fragmentation 
Exclusion criteria: 
• 
< 18 years of age 

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• 
Infectious, struvite stones.  
• 
Atypical collecting system anatomy that prolongs the case (ureteral 
stricture, malrotated kidney, infundibular stenosis, ureteral duplication) 
4.0 
Enrollment/Randomization 
 
Potential subjects will be identified during their pre-operative clinic visit.  Physician-
investigators will review medical chart and relevant pre-operative testing to make this 
determination.  Potential subjects will then meet with a member of the study team to 
read the consent in detail and discuss the study in full. 
 
After consent has been obtained, the study personnel obtaining consent will then obtain 
and assign the appropriate randomization for that subject. The patients will be 
randomized 1:1 to either standard laser lithotripsy or MOSES laser lithotripsy. 
Randomization will be performed using the redcap randomization application.  
 
5.0 
Study Procedures 
 
This is a blinded study. Our 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 patient 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, they 
will request that the laser be activated and provide the laser energy settings. The laser 
technician/nurse will follow randomization and add or remove the MOSES option. The 
surgeons will not be informed if they are 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, we will obtain clinical 
information including stone size, location, and stone analysis will be recorded.  
 
 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
All adverse events or unanticipated problems related to study participation will be 
reported in keeping with the IRB’s guidelines regarding such events.   
 

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7.0 
Study Withdrawal/Discontinuation 
 
If a subject wishes to withdraw from the study, he may do so by verbal or written request 
to the research team.  A subject may be withdrawn from the study by a physician-
investigator if determined to be in the subject’s best interest for medical reasons. 
 
8.0 
Statistical Considerations 
 
Overall OR duration may differ up to 10 min with an average OR time for URS estimated 
at approximately 1 hour. A power analysis with 80% power and an alpha of 0.05 requires 
a total recruitment of 106 patients with 53 patients in each treatment arm. Due to a 10% 
chance of withdrawal rate, the study will enroll 116 subjects for 106 subjects to complete 
the study. Statistical analysis of the obtained data will include a student T-test for 
comparison of two continuous variables and chi-squared for categorical variables. If 
enough events occur to warrant a multivariate analysis, a Cox regression utilizing 
forward selection will be performed. 
 
8.1 
Endpoint Considerations 
The primary endpoint of interest will reduction in total laser time and total 
OR time. Secondary endpoints will evaluate complication rates using the 
Clavien-Dindo score.   
 
9.0 
Privacy/Confidentiality Issues 
 
All information obtained from the medical record will be kept secured in a password 
secured REDCap database and only accessed by study personnel.  Manual entry will be 
performed and double entry verification will occur between research nurses and study 
personnel.  Data will undergo regular backups during data entry.  All data will be de-
identified from the patient, and the key for the de-identification process will be 
maintained in a secure location.  The presentation of the results of this study will 
maintain patient confidentiality. 
 
10.0 Follow-up and Record Retention 
 
Enrollment for this study is expected to be completed within 12 months of initiation.  
Identifiable data will be kept until data analysis is complete.  A limited data set will be 
kept for a minimum of 7 years.