Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Phase: NA
Conditions: Stone Clearance
Sponsor: Boston Scientific Corporation

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
DOC No.: 1005553 
Revision: A 
State: under review 
ECO No: GEN-0006361  
 
 
QF-1044300 Rev. B 
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Confidential 
 
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy 
Comparing Stone Breaking vs. Stone Dusting Settings  
 
Clinical Study Protocol 
 
 
Study Device:  
Lumenis pulse P120H Holmium Laser System  
 
Study Number: 
LUM-SBU-VP-15-01 
 
Protocol Revision: A 
 
Protocol Date:  
December 28  2015  
 
Sponsor Name: 
Lumenis, Ltd. 
 
Sponsor Address:  6 Hakidma St. 
 
Yokneam 20692 
 
Israel 
 
 
 

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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STATEMENT OF CONFIDENTIALITY 
The information contained herein is Confidential Information that remains the sole and exclusive 
property of Sponsor and is expressly subject to the terms and conditions of the Clinical Trial Agreement 
signed by both the Investigator and Sponsor 
 
Study Personnel 
Site 
Site Principal Investigator 
New York Methodist Hospital 
506 6th. Street, Brooklyn 
NY 11215  
USA   
Dr. Ivan Gunberger 
Chief Division of Urology and Professor of 
Clinical Urology 
Tel: (718) 780-5403     
email: ivg9002@nyp.org                 
 
Sponsor Contacts 
 
Shoham Arad, PhD 
Clinical Affairs Manager 
Phone No.:  +972-4-9599106 
Cell No.:  +972-52-6388087 
Fax No.:  +972-4-9599142 
shoham.arad@lumenis.com  
Lumenis Ltd. 
6 Hakidma St. 
Yokneam Industrial Park 
Israel 

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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Study Synopsis 
Study Title 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone 
Breaking vs. Stone Dusting Settings 
Protocol No: 
LUM-SBU-VP-15-01 
Device Name: 
Lumenis Pulse 120H Holmium Laser system 
Design 
Prospective, randomized, single center 
Planned Study period 
Initiation: January 2016 
Final Report: May 2016 
Objective 
Primary: Demonstrate the efficiency of stone dusting Vs stone breaking of the 
P120H holmium laser and 200 DFL ball tip fibers 
Secondary: Demonstrate the usability and safety of stone dusting 
Study population 
Twenty (20) subjects presenting with a renal stone and candidates for FURS 
Main Inclusion 
Criteria  
 
Subject will be older than 18 years of age 
 
Subject was diagnosed with renal calculi between 0.8 to 2 cm in size  
 
Subject is a candidate for FURS procedure 

Subject is willing and has signed the Informed Consent Form
Main Exclusion 
Criteria  
 
Underwent previous  PCNL or FURS in current kidney  
 
Need to perform concomitant procedure, other than FURS 
Investigational 
Treatment and study 
course 
A single FURS procedure will be performed with either high or low frequency 
holmium laser lithotripsy. Subjects will be randomized during enrollment to 
receive treatment with one of the two parameter sets. 
Follow up sessions: 
 
Day of discharge 

One month follow-up 
Criteria for Evaluation 
(endpoints) 
Primary Endpoints: 
 
Procedure time  
 
Usage of alternative stone extracting devices 
 
Catheterization time 
 
Time to hospital discharge 
 
Stone clearance based on 1 month follow-up imaging data 
Secondary Endpoints: 
 
Intraoperative Complications – based on Modified Clavien Classification 
 
Visibility during procedure 
 
Occurrence of retropulsion that interferes with procedure 
 
Ability to reach fragments during the procedure  
 
Fiber flexibility with scope deflection- any damage to fiber 
 
Fiber durability- deflection without losing energy/ efficiency  

Damage to scope

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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Table of Contents 
1 
Introduction .............................................................................................................................. 6 
1.1 
Background ................................................................................................................................ 6 
1.2 
Rationale for Evaluation ............................................................................................................. 7 
2 
Device Description ................................................................................................................... 7 
2.1 
Laser System – Lumenis Pulse P120H Holmium Laser .............................................................. 7 
2.2 
Fiber ........................................................................................................................................... 7 
3 
Study Design ............................................................................................................................ 8 
4 
Study Objectives ...................................................................................................................... 8 
4.1 
Primary....................................................................................................................................... 8 
4.2 
Secondary .................................................................................................................................. 8 
5 
Outcome Measures .................................................................................................................. 8 
5.1 
Primary Endpoints ...................................................................................................................... 8 
5.2 
Secondary Performance Endpoints ............................................................................................ 9 
5.3 
Safety ......................................................................................................................................... 9 
6 
Patient Population .................................................................................................................... 9 
6.1 
Source and Sample Size ............................................................................................................ 9 
6.2 
Eligibility ..................................................................................................................................... 9 
7 
Study Procedures .................................................................................................................. 10 
7.1 
Study duration and timelines .................................................................................................... 10 
7.2 
Study Measures ....................................................................................................................... 10 
7.3 
Screening Procedures .............................................................................................................. 11 
7.4 
Pre-treatment evaluation .......................................................................................................... 12 
7.5 
FURS pre-operative preparations- according to hospital routine of care ................................... 12 
7.6 
FURS procedure ...................................................................................................................... 13 
7.7 
Follow - up Regimen ................................................................................................................ 13 
8 
Study Analysis Plan ............................................................................................................... 14 
8.1 
Study Analysis .......................................................................................................................... 14 
8.2 
Interim analysis ........................................................................................................................ 14 
9 
Adverse Events (AE) .............................................................................................................. 14 
9.1 
Adverse Events Definitions....................................................................................................... 14 
9.2 
Reporting ................................................................................................................................. 16 
9.3 
Risk/ Benefit Analysis ............................................................................................................... 17 
10 
Administrative Procedures .................................................................................................... 17 
10.1 
Investigator Selection ............................................................................................................... 17 
10.2 
IRB / Ethical Committee Approval ............................................................................................ 18 
10.3 
Informed Consent ..................................................................................................................... 18 

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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10.4 
Subject Withdrawal/Dropouts ................................................................................................... 18 
10.5 
Case Report Forms/Data Collection ......................................................................................... 19 
10.6 
Required Documentation .......................................................................................................... 19 
10.7 
Subject’s Financial Compensation ............................................................................................ 20 
10.8 
Device Use/Accountability ........................................................................................................ 20 
10.9 
Training Requirements ............................................................................................................. 20 
10.10 
Modification of Protocol ........................................................................................................ 20 
10.11 
Data Retention/Archiving Data ............................................................................................. 20 
10.12 
Site Monitoring ..................................................................................................................... 20 
10.13 
Termination of Study ............................................................................................................ 21 
10.14 
Reporting Requirements ....................................................................................................... 21 
11 
References .............................................................................................................................. 22 
12 
Abbreviations and Terms ...................................................................................................... 23 
13 
Appendices ............................................................................................................................. 24 
 
 
 

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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1 Introduction 
1.1 Background 
The Lumenis Holmium Laser System family has been used for more than a decade for many procedures 
and specialties requiring excision, incision, ablation, and vaporization of tissue. 
The holmium:yittrium–aluminum–garnet (Ho:YAG) laser, known as the holmium laser, is a very 
commonly used laser in urological surgery [1, 2]. Its wavelength of 2,120 nm is very near the absorption 
peak of water (1,910 nm). As a result, it can be used for soft tissue-based applications as well as stone 
fragmentation. Since soft tissue is comprised primarily of water, the holmium laser energy is effective for 
excision, incision, ablation, and vaporization when in direct contact with soft tissue, and for coagulation 
when a few millimeters from soft tissue. If fired directly onto mucosa, the laser has an effective penetration 
depth of 300– 400 micron, thus limiting the collateral injury during tissue-based applications. Additionally, 
stones (both urinary and gastrointestinal) contain sufficient amount of water that can absorb laser energy 
leading to their fragmentation, thus facilitating their removal [3]. 
Holmium laser energy is emitted using flexible hard core fibers of varying diameters to the target tissue. 
The flexibility of the fibers enables reaching and treating areas that otherwise would have been hard or 
impossible to reach.  
The most common use of the holmium laser is for the fragmentation of urinary tract calculi (stones). 
Using rigid and flexible endoscopies the holmium fiber can be manipulated to reach stones located 
within the lower and upper regions of the urinary tract, including the renal pelvis [4, 7]. Once placed in 
the correct location the holmium laser is capable of fragmenting any type of stone. Comparison of this 
technique to external energy sources such as extracorporeal shockwave energy shows a clearly 
significant difference in stone fragmentation, favoring laser lithotripsy both for the absolute ability to 
fragment stones and the required number of sessions for complete removal [5]. Complications are 
minimal and transient [5]. Holmium laser lithotripsy has recently also been shown to be a safe and 
effective method for the management of large renal stones (2-3 cm) [6]. When the laser is combined 
with suction, large renal stone removal surgery can also be safe and effective, while decreasing the 
total operative time [13].   
Due to its flexibility advantage, holmium lithotripsy is mostly described as the modality of choice for 
retrograde ureteroscopic fragmentation of ureteral stones and small renal stones. During these 
procedures low power settings (low energy and frequency) are commonly used, due to the retropulsion 
effect of the holmium laser on the stone that prolong the lithotripsy process. These low power settings 
limit the fragmentation efficacy of the laser.  
Several methods to overcome retropulsion have been shown in in-vitro testing, including reduced 
energy per pulse used at higher frequencies and longer pulse duration [8, 9, 10]. The use of high 

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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frequency (40-80Hz) at low energy settings (0.2-0.5) has been suggested to enable fragmenting the 
stone into very fine particles (dust) that are washed out spontaneously. The use of decreased energy 
per pulse minimizes retropulsion, whereas the use of high frequency enables the application of the 
same accumulated energy to the stone, thus leading to similar lithotripsy. The application of these 
parameters in a clinical scenario has been limited, but explorative studies have shown that the use of 
stone dusting settings with high frequency & low energy can reduce operative time while demonstrating 
excellent clearance of renal stones at one month post procedure [14]   
1.2 Rationale for Evaluation 
The Lumenis Pulse P120H enables a wide range of working parameters that include use of high 
frequency at low energy. The use of the “stone dusting” set of parameters versus the commonly used 
“stone breaking” parameters may aid the physician in completing the procedure in a shorter period of 
time. The high frequency may reduce procedure time due to the ability to quickly fragment the stone, 
the resultant smaller stone fragments that can be washed out without the need for additional extraction 
procedures and the reduction of the retropulsion effect that necessitates repositioning of the flexible 
ureteroscope and fiber thus adding additional time to the procedure. 
The 200 DFL fiber demonstrated high performances in terms of flexibility, efficiency and durability 
especially in high repetition rates. This fiber is considered to be Lumenis’s optimal solution for stone 
treatment in flexible ureteroscopy thus will be utilized in both procedures.  
 
2 Device Description 
2.1 Laser System – Lumenis Pulse P120H Holmium Laser 
The Lumenis Pulse P120H is a high pulsed solid-state laser used for Urology procedures, worldwide. 
Importantly, both intended use and indications for use claims as well as underlying laser technology are 
similar to the marketed product. The activated laser is based on a flash lamp excited, Ho:YAG rod. The 
Ho:YAG rod derived photons are guided into the attached delivery system fiber. The system delivers a 
second, low powered laser in the visible wavelength spectrum of 650nm that enables aiming the high, 
invisible laser energy to the desired location.  
2.2 Fiber 
Slimline end-firing silica fibers are standard fibers used for laser lithotripsy procedures, to deliver laser 
energy from the system to the treatment site. The new 200 DFL flexible fiber is specially designed with a 
ball tip to facilitate fiber introduction through a fully deflected ureteroscope. The Slimline 200 micron fiber 
is single use, supplied ethylene oxide sterile. 

     
                                             
  
 
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Figure 1 - 200 micron fiber with ball tip 
3 Study Design 
This is a randomized, two arms, prospective, single center study. Subjects will undergo a single flexible 
ureteroscopic renal surgery (FURS) procedure for a kidney stone as part of this study, using the study 
device. Follow up visits are scheduled for the day of release from the hospital and at 1 month post 
procedure. Additional treatment sessions, if required, will be at the discretion of the investigator, as part 
of the site standard of practice. Additional treatment sessions will not be included in this study. 
4 Study Objectives 
4.1 Primary 
Demonstrate the efficiency of stone dusting Vs stone breaking of the P120H holmium laser and 
200 DFL ball tip fibers 
4.2 Secondary 
Demonstrate the usability and safety of stone dusting 
5 Outcome Measures 
5.1 Primary Endpoints 
 
Procedure time  
 
Usage of alternative stone extracting devices 
 
Catheterization time 
 
Time to hospital discharge 
 
Stone clearance based on 1 month follow-up imaging data 

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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5.2 Secondary Performance Endpoints 
 
Intraoperative Complications – based on Modified Clavien Classification 
 
Visibility during procedure 
 
Occurrence of retropulsion that interferes with procedure 
 
Ability to reach fragments during the procedure  
 
Fiber flexibility with scope deflection- any damage to fiber 
 
Fiber durability- deflection without losing energy/ efficiency  
 
Damage to scope 
 
5.3 Safety  
Incidence and severity of adverse events will be based on the modified Clavien classification system 
[12]  
6 Patient Population 
6.1 Source and Sample Size 
Subjects shall be selected by the physician within his patient population. One (1) site will participate in 
this study and will treat twenty (20) subjects. Enrolled subjects that did not complete the full course of 
the study will be discarded from performance analysis if they have not returned for the one month 
follow-up visits. 
6.2 Eligibility 
Each subject will be evaluated by the Investigator to assess his suitability for entry into this study 
according to the following criteria:  
6.2.1 
Inclusion Criteria 
6.2.1.1 Subject will be older than 18 years of age 
6.2.1.2 Subject was diagnosed with renal calculi meeting the following criteria: 
 Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm 
as defined by X-ray or CT.  
 Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm. 
6.2.1.3 Subject is a candidate for FURS procedure 
6.2.1.4 Subject is willing and has signed the Informed Consent Form 
 
Any of the following will exclude the subject from the study:  
6.2.2 
Exclusion Criteria  
6.2.2.1 Subject has undergone a previous treatment for stones in the same kidney 

     
                                             
  
 
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6.2.2.2 Subject requires another, concomitant procedure, other than FURS, to be performed during 
this treatment session. 
6.2.2.3 Female subject is pregnant 
6.2.2.4 Concomitant anticoagulant medication that cannot be suspended during surgery 
7 Study Procedures 
7.1 Study duration and timelines 
For each subject the duration of the study will be of 1 month. Subjects may remain hospitalized 
following surgery, based on physician’s discretion. Subjects will be followed at the day of their 
discharge from the hospital. Each subject will return for a follow-up visit at 1 month following the 
treatment procedure at which time they will have completed their participation in the study. 
It is expected that enrollment of all study subjects at the site will occur within 8-10 weeks from study 
initiation. 
7.2 Study Measures 
 
Various assessments will be performed throughout the study at different time-points as detailed 
in Intraoperative Complications – based on Modified Clavien Classification 
Table 1. 
7.2.1 
Objective Measures 
7.2.1.1 Blood workup: including CBC & BMP 
7.2.1.2 Urine workup: including urine analysis and urine culture (if applicable) 
7.2.1.3 Renal stone size and location will be performed using Computer Tomography  
7.2.1.4 All imaging verifying the diagnosis, pre-intervention images, intra-operative (during laser 
activation) images, immediate post-operative and follow-up images and relevant fluoroscopy 
and CT images will be recorded on electronic media for documentation, further analysis and 
data recording. 
Subject anonymity will be assured for all images by deleting any ID detail. Only the code for 
the Case Number in the study will appear on the records being transferred to the sponsor.  
7.2.1.5 Stone clearance status will be confirmed one month post discharge using non contrast 
abdominal Computed tomography (for Radioluscent calculus) or KUB X-ray combined with 
kidneys and bladder Ultrasound imaging (for radiopaque calculus).  
7.2.2 
Investigator Subjective Assessments 
7.2.2.1 Procedure Questionnaire will record subjective usability parameters such as ability to maintain 
fiber durability and deflection, retorpulsion and visibility impairment and resolution (due to 
bleeding or other disturbances), subjective assessment of lithotripsy efficiency, aspiration and 
combined procedures.  

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
Stone Breaking vs. Stone Dusting Settings 
 
 
 
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 
Intraoperative Complications – based on Modified Clavien Classification 
Table 1 – Assessments time-points  
Assessment 
 
Performed During Visit 
Baseline  
(Pre-operative) 
Perioperative 
Hospital  
discharge 
1 month follow-
up 
Subject assessment 
(ICF, medical history, 
demographics, 
inclusion/exclusion 
evaluation) 
X 
 
 
 
Imaging 
X (CT and / or 
X-ray) 
 
 
X (CT and / or X-
ray) 
Blood analysis (CBC & 
BMP) and urine 
analysis 
X 
 
X 
X 
Urine culture (if 
applicable) 
X 
 
 
X 
Physician Subjective 
Procedure 
questionnaire 
 
X 
 
 
Adverse Event 
Assessment 
 
X 
X 
X 
7.3 Screening Procedures 
7.3.1 
Subject Enrollment  
1. During the first visit, the investigator will screen the subject for eligibility to participate in the clinical 
study using the Inclusion, Exclusion criteria. During screening, the study physician will review the 
subject's medical history to ensure that the subject meets the study criteria.  
2. If the subject has met the preliminary study eligibility criteria, the study physician will obtain an 
informed consent from the subject, clearly indicating his/her understanding of the procedure, 
requirements and risks involved with study participation and other applicable treatment options.  
3. The subject will be enrolled to the study and the treatment will be scheduled. 
7.3.2 
Subject Identification 
At enrollment, each subject will receive an identifying number that will include a consecutive serial 
number. The subject identification number and the subject initials will be used to identify the subject 
during the entire study and will be entered in the subject's CRF for each treatment and photographs.   

     
                                             
  
 
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing 
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7.3.3 
Subject randomization 
Allocation of the treatment parameters used during the procedure will be performed using study 
randomized envelopes. The sponsor will provide the site with sealed envelopes containing “stone 
breaking” or “stone dusting” treatment parameters. Randomization will be divided into two groups of 
patients (1-10 and 11-20) with randomization ratio of 1:1 in each group. The randomization list will take 
into consideration additional subjects that will be required to replace subjects that have dropped from 
the study. If any subject drops out from the study and is replaced by another subject randomization will 
continue as per the original randomization scheme (this new subject will not receive the randomization 
of the subject that was replaced). 
7.4 Pre-treatment evaluation 
The following examinations are included in the standard of practice for subjects with renal calculi and 
may have been performed prior to the subject enrollment. Medical history as well as measurements 
that were completed prior to study enrollment will be used as baseline data for the study. 
 
A complete history and physical examination and total duration of the patient's symptoms;  
 
Blood and urine tests including urinalysis, urine cultures, complete blood count (CBC). 
 
Stones sizes and locations measured using the most resent X-ray or abdominal Computed 
Tomography imaging performed. 
 
7.5 FURS pre-operative preparations- according to hospital routine of care 
7.5.1 
Anesthesia 
The subject will be put under regional (spinal) anesthesia or general anesthesia, per standard hospital 
practice for FURS procedures. 
7.5.2 
Preoperative antibiotics  
The subject will be given intravenous preoperative antibiotics per standard hospital practice. 
7.5.3 
Retrograde guide introduction 
The subject will be placed in the dorsal lithotomy position. A cystoscope will then be inserted through 
the urethra into the bladder. If a prior ureteral stent is present the vesicle end of the ureteral stent will 
be removed outside the external urethral meatus, a guidewire will be inserted through its lumen up to 
the renal pelvis (under fluoroscopy).  A ureteral catheter will then be used to perform retrograde 
pyelography under fluoroscopy. If no previous stenting was performed ureteral catheterization of the 
treated side will be performed and guide introduction to the kidney will be performed under fluoroscopy 
through the ureteral meatus as commonly performed.  
This part of the procedure is complete when at least one guidewire is left in place. This guidewire will 
remain throughout the procedure as a safety measure.   

     
                                             
  
 
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7.5.4 
Ureteral dilation and access sheath 
If ureteral dilation is needed, mainly when ureteral stenting wasn't performed prior to the surgery, it will 
be performed using consecutive ureteral dilators or ureteral balloon dilator per standard hospital 
practice. 
Introduction of a ureteral access sheath will be introduced per standard hospital practice. 
7.6 FURS procedure 
A flexible ureteroscope will be inserted over a guidewire to the kidney, with or without a ureteral access 
sheath, as needed. Renoscopy will then be performed and all calculi will be localized.  
7.6.1 
Fiber introduction 
After the stones are visualized, the 200 DFL fiber is introduces through the scope (either partially 
deflected or fully deflected, till visible in the end of scope. 
7.6.2 
Lithotripsy 
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system and the 200 DFL ball 
tip fiber using the suggested parameter range sets listed below. The treatment set used will be 
predefined according to the treatment group the subject was randomized to.  
Task 
Group I 
(stone breaking)
Group II 
(stone dusting)
Energy per pulse
1 - 2.0 J
0.2 - 0.5 J
Frequency 
10 – 30 Hz 
70 – 80 Hz 
Maximum power possible
40 W*
40 W*
 
Do not exceed the maximum 40W energy 
7.6.3 
Stone clearance 
In all stages of the procedure, stone fragments extraction may be assisted, if needed by the use of 
baskets, forceps or saline flushing. Use of such accessories will be recorded. 
At the end of stone fragmentation procedure, the renal pelvis will be inspected again and a “stone-free 
status” will be determined by the surgeon. Remnant fragments of 1 mm will be included under the 
“stone-free status” category. Complete stone clearance will be confirmed by intraoperative fluoroscopy. 
Finally, the ureter will also be inspected ureteroscopically and fluoroscopically with the administration of 
contrast medium to detect possible urine extravagation and remnant stone fragments.  
7.6.4 
Stent placement 
A double-J ureter catheter may be introduced, per standard hospital practice. 
7.7 Follow - up Regimen 

     
                                             
  
 
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Each subject will be evaluated by the physician post the procedure as per standard of care to assess 
subject wellness. Subjects will be released from the hospital per the hospital standard practice. Each 
subject will return one month following the procedure for a follow-up visit to assess stone clearance and 
subject well-being. Evaluations during each of these visits will be performed as described in Table 1. 
Additional unscheduled visits or examinations performed that are not part of the standard of care will be 
recorded in a dedicated Case Report Form (CRF). 
8 Study Analysis Plan 
8.1 Study Analysis 
The results of the study: subject demographics, baseline assessments, treatment parameters, 
treatment evaluations and follow-up assessments will be summarized and descriptive analysis will be 
performed. Continuous variables will be compared between the two groups using independent 
samples Student’s t-test or Mann-Whitney U test. A p-value < 0.05 will be considered as 
significant. 
Adverse events reported will be listed, documenting course, outcome, severity, and possible 
relationship to the treatment. The modified Clavien classification will be used to evaluate severity of 
Adverse Events [12]. 
8.2 Interim analysis 
Interim analysis of the immediate post-operative data will be performed after at least 10 subjects 
underwent surgery in order to assess the immediate study results. Treatment safety and both primary 
and secondary endpoints will be analyzed following the completion of all study subjects follow-up 
period. 
9 Adverse Events (AE) 
9.1 Adverse Events Definitions 
9.1.1 
Adverse Event 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device 
9.1.2 
Adverse Device Effect 
Adverse event related to the use of an investigational medical device. Adverse Device Effect can be an 
anticipated serious adverse Device Effect which by its nature, incidence, severity or outcome has been 
identified in the risk analysis report or unanticipated if it has not been identified in the risk analysis 
report. 

     
                                             
  
 
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9.1.3 
Serious Adverse Events 
NOTE: The term serious is not synonymous with severity, which may be used to describe the intensity 
of an event experienced by the subject.).  An AE that does not meet any of the below criteria will be 
classified as non-serious. 
A serious adverse event is any event that: 
1. led to death, 
2. led to serious deterioration in the health of the subject, that either resulted in 
2.1. a life-threatening illness or injury, or 
2.2. a permanent impairment of a body structure or a body function, or 
2.3. in-patient or prolonged hospitalization, or 
2.4. medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
3. led to foetal distress, foetal death or a congenital abnormality or birth defect 
Any adverse events or complications reported by the patient or observed by the physician that occur 
during or after treatment with the device will be recorded in the medical record or source document and 
on the dedicated Case Report Form.  The investigator will determine if the AEs are device related or 
procedure related.  This assessment shall include the onset date, resolution date, severity, 
seriousness, frequency, additional treatment required and outcome.   
Each adverse event should be assessed according to the following criteria: 
9.1.4 
Classification 
9.1.4.1 Severity (based on Clavien classification) 
Each adverse event should be assessed for its severity, or the intensity of an event experienced by the 
subject. 
 
Mild: Awareness of a sign or symptom that does not interfere with the subject’s activity or is 
transient, resolved without treatment and has no sequelae. 
 
Moderate: May interfere with the subject’s usual activity and require additional intervention and/or 
treatment, and may have additional sequelae. 
 
Severe: Significant discomfort to the subject and/or interferes with the subject’s activity. Additional 
intervention and or treatment are necessary. Additional sequelae occur. Severe is used to describe 
the intensity of an event experienced by the subject.  
9.1.4.2 Relationship of AE to the Device 

     
                                             
  
 
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Each adverse event should be assessed for its relationship to the device or procedure as identified as 
follows: 
 
Device: This category should be restricted to adverse events directly attributable to the lithotripsy 
procedure 
 
Procedure: This category should be restricted to adverse events inherent to the procedure 
irrespective of the fiber performance   
Use the following categories for assigning the certainty of the relationship: 
 
Definitely Related: An AE is definitely related if it is obvious, certain or there is little doubt 
regarding the relationship 
 
Possibly Related: An AE is possibly related if it is capable of being related but relatively unlikely. 
 
Not Related: An AE is not related if it is determined that there is no plausible association. 
 
Unknown: Use this term if there is insufficient information to determine if the AE is related to the 
device or procedure. 
9.1.4.3 Pre-existing Conditions 
A pre-existing condition should not be reported as an adverse event unless there has been a 
substantial increase in severity or frequency of problems, which has not been attributed to natural 
history. 
9.1.4.4 Diagnosis 
There should be an attempt to report a “diagnosis” rather than the individual signs, symptoms and 
abnormal laboratory values associated with the diagnosis. However, a diagnosis should be reported 
only if, in the Investigator’s judgment, it is relatively certain (i.e., definite or possible). Otherwise 
individual signs, symptoms and abnormal laboratory values should be reported as the adverse events. 
9.2 Reporting 
9.2.1 
Adverse Events (AE) and Severe Adverse Events (SAE) Reporting 
All serious adverse events, whether or not deemed expected or device-related, must be reported to the 
clinical monitor immediately or within 24 hours of knowledge by telephone (see below). A written report 
must follow within five (5) working days and is to include a full description of the event and sequence.  If 
the Lumenis monitor cannot be reached, the site personnel will directly contact the Lumenis 
Communication Center (USA) at +1-877-586-3647. 
If an anticipated adverse event occurs at any time during or after the use of the study device, the 
Investigator must report it to Lumenis. If the anticipated adverse event, in the opinion of Lumenis or the 
Investigator, is likely to affect the safety of the subjects or the conduct of the study, the IRB/ethic 
committee will be notified of the effect as required by the authorized representative.  

     
                                             
  
 
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The Investigator shall report to the EC and regulatory authorities serious adverse events and device 
deficiencies that could have led to a serious adverse device effect, if required by the national 
regulations or by the EC. 
9.3 Risk/ Benefit Analysis 
9.3.1 
Anticipated Procedure Related Adverse Events 
Anticipated adverse events that are related to the FURS procedure performed as part of this study and 
as established in the literature are noted below [11]. These complications are related to FURS, whether 
or not lithotripsy is performed, and regardless of the method that is used for either removal or 
fragmentation of the stone. 
 
Intraoperative complications: bleeding, perforation of the ureter or renal pelvis wall, ureteral 
avulsion, subcapsular hematoma 
 
Postoperative complications: urinary tract infection, hydronephrosis, colic pain, ureteral strictures, 
steinstrasse 
9.3.2 
Anticipated Device Related Adverse Events 
The potential risks related to the system may include: kidney perforation, lacerations and hematomas. 
Nevertheless, this modified system is based on the previous marketed family of Ho:YAG lasers that is 
already largely used in the clinical arena, and for the same indications. The use of Ho:YAG for 
fragmentation of upper renal stones has been shown to be safe and effective with a very low rate of 
complications [77]. 
Finally, the modified system underwent a thorough series of pre- clinical verification and validation 
testing to ascertain its maintained safety and performance as well as the safe and effective use of the 
200 micron fiber with flexible ureteroscopes. 
9.3.3 
Anticipated Benefits 
Holmium laser energy has been shown to be able to fragment any stone composition. Due to the 
flexibility of the delivery device (fiber) any location in the kidney collecting system can be reached. 
Combining these advantages with the ability to fragment the stone into particles that will wash out 
naturally and do not require retrieval, as well as increased efficiency due to reduced movement of the 
stone during the procedure may lead to reduced procedure time and procedure complications as 
compared to the commonly used parameters used for lithotripsy.  
10 Administrative Procedures 
10.1 Investigator Selection 
The investigator must be of good standing as an investigator and knowledgeable in relevant areas of 
clinical research to ensure adherence to the requirements of the protocol, including the protection of 

     
                                             
  
 
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human subjects.  Other site personnel must have appropriate research experience and infrastructure to 
ensure adherence to the protocol and enrollment of sufficient numbers of evaluable subjects. The 
curriculum vitae (CV) of the Investigator will be maintained in the Sponsor files as documentation of 
previous medical training, and federal databases will be searched to ensure that the investigator and/or 
the site are not prohibited from engaging in federally sponsored clinical research.  The Principal 
Investigator will sign the signature page of this protocol, agreeing to comply with all applicable 
government regulations and the requirements of this study. 
10.2 IRB / Ethical Committee Approval 
This clinical study will be conducted according to all applicable regulations under the Medical Device 
Directive and in accordance with the ICH Good Clinical Practice and local laws and regulations relevant 
to the use of medical devices. 
An Ethical Committee (EC or IRB) will approve the clinical study protocol prior to study initiation. 
Approval will be indicated in writing with reference to the final protocol number and date. 
Details regarding the IRB / EC 's constitution including the names of its members, their qualifications 
and what function they perform on the board (e.g., chairman, specialist, lay-member) will be made 
available to enable Lumenis and the Investigator to conform to regulations governing research on 
experimental devices. 
10.3 Informed Consent 
Prior to the procedure, the Investigator or his/her delegate must explain to each subject (or the 
subject’s legally authorized representative) the nature of the study, its purpose, expected duration, and 
the benefits and risks of study participation.  After this explanation and before entering the study, the 
subject (or legally authorized representative) must voluntarily sign and date the IRB (EC) -approved 
Informed Consent form. 
10.4 Subject Withdrawal/Dropouts 
The subjects will be advised in the written Informed Consent form that they have the right to withdraw 
from the study at any time without prejudice, and may be withdrawn at the Investigator’s/Lumenis’ 
discretion at any time. In the event that a subject drops out of the study or is withdrawn from the study, 
the Exit/Termination CRF should be completed. On the withdrawal page the Investigator should record 
the date of the withdrawal, the person who initiated withdrawal and the reason for withdrawal. 
Reasonable effort should be made to contact any subject lost to follow-up during the course of the 
study in order to complete assessments and retrieve any outstanding data and study supplies. The 
records of subjects who terminate prior to completing the study will be retained and the reason for 
termination will be documented. 
The following are possible reasons for subject dropout/withdrawal: 

     
                                             
  
 
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 
Adverse event that would prevent subject compliance with the protocol; 
 
Subject withdrawal of consent; 
However, every effort should be made to see that subject is followed for the remainder of the study 
even if subject is unable or unwilling to comply with the protocol. 
10.5 Case Report Forms/Data Collection  
The Investigator is responsible for completely and accurately recording study data in the appropriate 
sections of the CRFs provided by Lumenis.  The CRFs must be signed by the Investigator or by his/her 
authorized person as designated in a note to file. 
The monitor will ensure the quality of data recording at each investigational site by comparison to 
supporting source documents during periodic site visits.  Adherence to proper recording of information 
as well as assuring that corrections are being made will also be addressed during these periodic visits. 
Data will be recorded on the following CRFs. Where data is not located in the subject’s source file, the 
CRF will be the source for this data. 
 
Eligibility Form 
 
Pre-treatment Evaluation Form 
 Demographic 
 General medical history 
 Specific medical history 
 
Randomization Form 
 
Treatment information form 
 
Post Treatment Information Forms (follow-up forms) 
 
Subjective assessment Forms 
 
Adverse Event Form 
 
Study completion Form 
10.6 Required Documentation 
Prior to starting the clinical study, the following documents must be submitted or returned to Lumenis by 
the Investigator: 
 
Signed Clinical Trial Acknowledgement for the protocol  
 
Signed Clinical Evaluation Agreement 
 
Curriculum vitae of the Principal Investigator 
 
Signed Financial Disclosure Statement for each investigator 
 
Written approval from the Ethical Committee of both the protocol and informed consent form 

     
                                             
  
 
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10.7 Subject’s Financial Compensation 
Subjects participating in this study will not be compensated for participating in this study.  
10.8 Device Use/Accountability 
The evaluation site personnel will maintain records of the model and serial number of the device (if 
appropriate) used for each treatment during the conduct of the study. The device along with the 
associated delivery and accessories are to be maintained by the research sponsor with reasonable 
care being taken by the Investigators and facility to prevent damage to, or unauthorized use of the 
equipment. The device along with associated delivery and accessories are not to be used for other 
non-research subjects during the conduct of the evaluation. 
10.9 Training Requirements 
PI and all study personnel are well familiar with the procedure and device operation including all related 
tools and equipment. No training or additional instructions are required prior to study initiation. 
10.10 Modification of Protocol 
The protocol may be amended with the agreement of the sponsor and upon notification of and approval 
by the IRB / EC. 
Investigators should review the contents of this protocol.  Subsequent alterations should only be made 
in writing in conjunction with the sponsor.  
Medically significant amendments to the protocol (e.g., changes that increase the risk or the 
inconveniences for the patient, inclusion of new categories of patients, significant modifications to the 
study device, etc.) must be approved by the local IRB / EC prior to implementation and authorized 
representative, as applicable.  
10.11 Data Retention/Archiving Data 
The Investigator must keep the following documents in a secure place for at least 2 years after the last 
clearance of a marketing application or at least 2 years have elapsed since the formal discontinuation 
of clinical development of the investigational product. 
 
A signed copy of the final protocol and amendments. 
 
Copies of the subjects’ evaluation forms, data clarification forms and any associated subject-related 
raw data or where applicable, authorized copies of raw data. 
 
Clinical photographs stored on CD-ROM or similar electronic media. 
 
The subjects’ signed Informed Consent forms. 
10.12 Site Monitoring 

     
                                             
  
 
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The study monitors are designated as agents of Lumenis and are assigned to oversee the conduct and 
progress of the study and to be the principal communication link between Lumenis and investigator.  
The study monitors will be involved in monitoring of sites and records, to ensure continued compliance 
with the protocol and adequacy of the investigator and the facility to carry out the study.   
The study will be monitored by representatives of Lumenis Medical, Ltd. by telephone, in writing and 
during on-site visits.  At a minimum, site visits will be scheduled prior to the initiation of the study, and at 
the end of the study. The purpose of site visits will be to ensure compliance with the investigational 
plan, to ensure appropriate use of investigational devices, and to inspect and retrieve study data. 
10.13 Termination of Study 
Lumenis reserves the right to discontinue the study at any time for administrative or other reasons.  
Written notice of study termination will be submitted to the investigator in advance of such termination.  
Termination of a specific site can occur because of (but is not limited to) inadequate data collection, low 
subject enrollment rate, achievement of the total enrollment, or non-compliance with the protocol or 
other clinical research requirements 
10.14 Reporting Requirements 
The investigator must promptly report to Lumenis any withdrawal of IRB / EC approval at the site.  
Additional reporting requirements include: 
 
Notify Lumenis’ designee and the IRB / EC of any severe adverse device effect, whether 
anticipated or unanticipated, that occurs during the study as soon as possible, but in no event later 
than 10 working days after the investigator first learns of the effect. This report is to include a 
description of the effect, subsequent treatments, clinical outcomes, and outcome diagnoses.  If the 
site personnel are not sure whether an event meets these criteria they should call the clinical 
monitor. 
 
Notify Lumenis or Lumenis’s designee and the IRB / EC immediately (within 24 hours) if an 
emergency situation arises in which the subsequent treatment, in the best interests of the subject, 
resulted in a deviation from the protocol.  This should be followed with written confirmation that 
describes the emergency action and outcomes, to Lumenis and the IRB / EC within 5 working days. 
 
Report to the IRB / EC and Lumenis, within 5 working days, the use of the study device without 
signed informed consent from the subject. 
 
Report adverse events in accordance with 21 CFR 803. 
 
Submit regular progress reports to the IRB / EC and Lumenis or Lumenis’ designee, as requested 
by the investigators or IRB/ EC. 
 
Submitting a final report on the study to the IRB / EC and Lumenis or Lumenis’s designee within 
3 months after termination or completion of the study 
 
 

     
                                             
  
 
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11 References  
1. Elmansy HM, Kotb A, Elhilali MM. Holmium laser enucleation of the prostate: long-term durability of 
clinical outcomes and complication rates during 10 years of followup.J Urol. 2011 Nov;186(5):1972-
6.  
2. Hecht SL, Wolf JS Jr.  Techniques for holmium laser lithotripsy of intrarenal calculi.Urology. 2013 
Feb;81(2):442-5. 
3. Chan KF, Pfefer TJ, Teichman JM, Welch AJ. A perspective on laser lithotripsy: the fragmentation 
processes. J Endourol. 2001 Apr;15(3):257-73. Review. 
4. Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser 
lithotripsy for stones >2 cm: a systematic review and meta-analysis.J Endourol. 2012 
Oct;26(10):1257-63.  
5. Arrabal-Polo MA, Arrabal-Martín M, Miján-Ortiz JL, Valle-Díaz F, López-León V, Merino-Salas S, 
Zuluaga-Gómez A.. Treatment of ureteric lithiasis with retrograde ureteroscopy and holmium: YAG 
laser lithotripsy vs extracorporeal lithotripsy. BJU Int. 2009 Oct;104(8):1144-7. 
6. Hyams ES, Munver R, Bird VG, Uberoi J, Shah O. Flexible ureterorenoscopy and holmium laser 
lithotripsy for the management of renal stone burdens that measure 2 to 3 cm: a multi-institutional 
experience. J Endourol. 2010 Oct;24(10):1583-8. 
7. Sofer M, Watterson JD, Wollin TA, Nott L, Razvi H, Denstedt JD Holmium:YAG laser lithotripsy for 
upper urinary tract calculi in 598 patients. J Urol. 2002 Jan;167(1):31-4. 
8. Kalra P, Le NB, Bagley D. Effect of pulse width on object movement in vitro using holmium:YAG 
laser. J Endourol. 2007 Feb;21(2):228-31. 
9. Sea J, Jonat LM, Chew BH, Qiu J, Wang B, Hoopman J, Milner T, Teichman JM. Optimal power 
settings for Holmium:YAG lithotripsy. J Urol. 2012 Mar;187(3):914-9. 
10. Spore SS, Teichman JM, Corbin NS, Champion PC, Williamson EA, Glickman RD Holmium: YAG 
lithotripsy: optimal power settings.. J Endourol. 1999 Oct;13(8):559-66. 
11. Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser 
lithotripsy for stones > 2 cm: a systematic review and meta-analysis. J Endourol. 2012 
Oct;26(10):1257-63.  
12. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with 
evaluation in a cohort of a 6336 patients and results of a survey. Ann Surg 2004;240:205–13 
13. SK Mishra, V Murali, JS Singh, RB Sabnis, MR Desai. High power Holmium-YAG laser combined 
with suction for large bulk renal calculus. World Congress of Endourology, October 2015. 
14. RB Sabnis, A Jain, JS Chhabra, SK Mishra, MR Desai, Prospective randomized study between 
high power laser & low power laser through FURS for treating renal stones >2cm size, World 
Congress of Endourology, October 2015. 
 

     
                                             
  
 
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12 Abbreviations and Terms 
PCNL 
Percutaneous Nephrolithotomy 
FURS
Flexible ureteroscopic renal surgery
CBC
Cell blood count
AE 
Adverse Event 
SAE
Serious Adverse Event
BUN 
Blood urea nitrogen 
CRF
Case Report Form
IRB
Institutional Review Board
EC 
Ethical Committee 
Ho:YAG
Holmium
CT 
Computer Tomography 
US
Ultrasound Sonography
Hz 
Hertz (frequency unit) 
J 
BMP
Joule (energy unit) 
Basic Metabolic Panel
W
Watt (power unit)
KUB x-ray 
Kidney, ureter, bladder x-ray 
 
 

     
                                             
  
 
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13 Appendices 
Appendix I 
Study Flow Chart  
 
Assessment 
Performed During Visit 
Baseline  
(Pre-operative) 
Perioperative 
Hospital  
discharge 
1 month follow-
up 
Subject assessment 
(ICF, medical history, 
demographics, 
inclusion/exclusion 
evaluation) 
X 
 
 
 
Imaging 
X (CT and / or 
X-ray) 
 
 
X (CT and / or X-
ray) 
Blood analysis (CBC & 
BMP) and urine 
analysis 
X 
 
X 
X 
Urine culture (if 
applicable) 
X 
 
 
X 
Physician Subjective 
Procedure 
questionnaire 
 
X 
 
 
Adverse Event 
Assessment 
 
X 
X 
X 

     
                                             
  
 
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Appendix II 
Clinical Trial Acknowledgement 
 
I have read and understand the foregoing protocol, and agree to conduct the clinical trial as outlined 
herein and in accordance with Good Clinical Practices (ICH-E6) as well as with local and universal 
regulations pertaining to clinical trials. 
 
 
 
Investigator’s Signature 
 
Date 
Name 
 
 
Clinic 
 
 
Street Address 
 
 
City, State & Zip Code 
 
 
Country 
 
 
Phone # 
 
 
Fax # 
 
 
E-mail Address