A Randomized Controlled Trial Comparing Efficacy, Ergonomics, and Safety of ILY Robotic System vs Manual Flexible Ureteroscopy in Patients Undergoing Laser Lithotripsy for Kidney Stones
Phase: NA
Conditions: Kidney Stones, Urolithiasis
Sponsor: Albert El Hajj

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A Randomized Controlled Trial Comparing Efficacy, 
Ergonomics, and Safety of ILY Robotic System vs Manual 
Flexible Ureteroscopy in Patients Undergoing Laser 
Lithotripsy for Kidney Stones 
 
iFURS Trial: ILY Robotic System vs Manual Flexible 
UReteroScopy for Kidney Stone Treatment 
Protocol Version 2.1 
March 11, 2025 

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Protocol Content 
1.0 Abstract 
2.0 Objectives 
3.0 Background and Innovation 
4.0 Device Description 
5.0 Study Design 
5.1- Participants 
5.2- Sample Size Calculation 
5.3- Recruitment Strategies 
5.4- Blinding and Randomization 
5.5- Intervention 
6.0 Study Measures 
7.0 Schedule of Activities 
7.1- Pre-procedure Evaluation 
7.2- Pre-Discharge Evaluation 
7.3- Postoperative Follow Up 
7.4- Unscheduled Follow Up Visits 
8.0 Data Analysis and Significance 
9.0 Maintaining Records 
10.0 Adverse Events and Safety Monitoring 
11.0 Ethical Considerations and Dissemination 
13.0 Conflicts of Interest 
14.0 Bibliography 

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1.0 Abstract 
Background: The rising prevalence of kidney stone disease (KSD) has increased the 
need for ureteroscopy (URS). Innovations like digital flexible URS and robotic 
technology have improved ergonomics and reduced surgeon radiation exposure. The 
ILY® robotic URS system, a novel wireless-controlled manipulator, has shown 
promising efficacy and safety, but no direct comparisons to manual flexible URS (fURS) 
exist. 
Objectives: Our primary objective is to evaluate whether robotic ureteroscopic lithotripsy 
using the ILY® robotic system provides the same efficacy, measured by the stone free 
rate. Secondary outcomes will evaluate safety, measured by peri-operative and 30-day 
post-operative complication rate, in comparison with the manual fURS. Additionally, 
intra-operative ergonomics, surgeon safety in terms of radiation exposure, and 
intraoperative parameters like operative time and conversion rate will be evaluated 
Methods: This is a multicenter, parallel group, randomized controlled noninferiority trial 
with a 1:1 allocation ratio between the treatment and control groups. The treatment group 
will undergo laser lithotripsy with robotic fURS utilizing the ILY® robotic system and 
the control group with manual fURS. The NASA Task Load Index will be used to assess 
ergonomics and “Instadose” badges will be measuring the surgeon’s radiation exposure. 
Analysis Primary analysis will follow an intention-to-treat approach. Stone-free rates 
between groups will be compared using the Chi-square or Fisher’s exact test. 
Perioperative and 30-day postoperative outcomes will be compared using chi-square tests 
or logistic regression with adjustments for covariates. For the NASA Task Load Index 
scores, independent t-tests or Mann-Whitney U tests will be used, depending on 
normality. Secondary outcomes will be analyzed similarly to the primary outcomes. 
Significance This is the first clinical trial to evaluate the ILY robot system in comparison 
to manual fURS, providing pioneering data on its efficacy, safety, and postoperative 
outcomes. 
Source of funding: AUB Intramural Funding sponsored by the Medical Practice Plan

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2.0 - Objectives: 
Our primary objective is to evaluate whether robotic ureteroscopic lithotripsy using the 
ILY® robotic system provides the same efficacy, measured by the stone free rate*. 
Secondary outcomes will include safety, assessed by the perioperative and 30-day 
postoperative complications in comparison with the manual flexible ureteroscopy. 
In addition, we will assess intra-operative ergonomics, surgeon safety in terms of 
radiation exposure, and intraoperative parameters (operative time, draping time, docking 
time, lasing time, conversion rate, etc...) 
 
*Stone free rate will be defined as the absence of residual fragments on NCCT scan. [1] 
 
3.0- Background and Innovation 
The prevalence of kidney stone disease (KSD) has surged recently [2, 3] increasing the 
demand for therapeutic interventions, particularly ureteroscopy (URS) [4, 5]. In recent 
history, the development of digital flexible URS proved to be a significant leap in the 
field, with the addition of high-powered laser technology making laser lithotripsy via 
URS more viable and efficient. Currently, the introduction of robotic technology is 
making URS more comfortable and safer for the surgeon by improving its ergonomics 
and avoiding surgeon exposure to ionizing radiation [6-8]. 
Previous publications have shown that different URS techniques and equipment 
have differences in muscle activation as assessed by surface electromyography (EMG) 
[9]. This finding called for individual studies to assess different techniques and URS 
equipment. Studies looking at novel robotic URS systems explored the possible 
advantages of robotic URS over conventional URS, including increased range of motion, 
improved ergonomics, intuitiveness, and instrument stability [10-12].For instance, some 
robotic technologies improve ergonomics by introducing controllers or wireless consoles 
[11, 12], such as the Sensei robot (Hansen Medical, Mountainview, CA, USA) or the 
EasyUretero (ROEN Surgical Inc., Daejeon, Korea). Ergonomics and surgeon wellbeing 
have been shown to contribute to patient safety [13]. One study comparing the efficacy of 

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a robot designed by Elmed (Ankara, Turkey) for flexible URS to manual URS revealed 
better performance in some parameters by the new robotic flexible URS, such as less 
fragmentation/dusting time and higher stone-free rate at 3 months [14]. 
Moreover, wireless controllers allow surgeons a safe distance away from the 
source of ionizing radiation [15]. The harms of ionizing radiation are well known [16, 17] 
and have been studied in urologists [18] who might receive up to 1,100 mrem per one 
hour of fluoroscopy time, while the United States Nuclear Regulatory Commision 
recommends an annual whole-body exposure of 5,000 mrem for radiation workers [19]. 
URS involves a lot of potential radiation exposure [20, 21] which led to studies looking at 
solutions to mitigate this risk [22, 23], including justification, optimization, and limitation 
of radiation. Distance and shielding can eliminate such risks completely, and the remote 
nature of some robotic URS techniques allows surgeons to distant and shield themselves 
more effectively [11, 12]. 
Such promising results highlight the potential of robotic flexible URS, considering 
that its wide-scale adoption has yet to be seen. ILY® (Sterlab, Vallaruis, France) is a 
novel robotic URS manipulator that is adaptable to multiple types of URS and access 
sheaths and is controlled by a wireless controller. ILY® uniquely addresses the challenges 
in manual fURS including surgeon fatigue, procedural variability, and ergonomic strain 
by introducing a remote control, which allows the surgeon to work easily at a distance 
from the patient and decreases the exposure to ionizing radiation[15]. Also, the ILY® 
robotic system integrates enhanced dexterity and precise laser guidance offering the 
potential for improved procedural efficiency and outcomes[15]. 
In its first prospective clinical experience, the ILY® showed efficacy and safety in 
the clinical setting [24]. In another clinical experience by Farré et al [25], no 
intraoperative complications or device-related failures were reported. To our knowledge, 
no direct comparative studies comparing ILY® to the standard of care (manual fURS) 
have been conducted or reported in the literature. 
This study represents the first clinical trial to evaluate the ILY robot system in 
comparison to manual fURS, providing pioneering data on its efficacy, safety, and 
postoperative outcomes marking a significant advancement in the field. 
 
4.0 – Device Description 
ILY® (STERLAB, Vallauris, France) is a ureteroscope holder which can be 
telemanipulated by the surgeon with a wireless controller while placed close to the 
patient (Figure 5). Unlike the rest of the robots used in endourology, ILY has a remote 

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control similar to the PlayStation’s joystick (Figure 6). This helps the surgeons keep a 
distance from the source of ionizing radiation. 
 
Figure 5. ILY® robot. 
 
 
Figure 6. Placement of surgeon’s hands and movements to manipulate (A): Flexible 
ureteroscope; (C): ILY® robot. Arrows represent how to perform different movements 
and the corresponding directions of hands, fingers, scope and movements. 
The ILY® ureteroscope holder is compatible with all types of ureteroscopes available on 
the market. (reusable and single use). It is also compatible with most of the sheath brands 
and their different sizes. The type and size of the sheath can be selected on the tactile 
screen during the UAS placement, and the sheath holder modulates according to it. 

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Since there ILY robot has the advantage of maneuverability, it can be rotated +/- 360 
degrees. In addition, placing the scope over a surface increases stability and accuracy 
which in turn reduces the movements of the scope and fiber tip during the renal stone’s 
lithotripsy. 
In terms of ergonomics in fURS, Ong et al. [26] mentioned that this device is of great 
importance for surgeons who perform several surgeries per day and for long procedures 
where the manual handling of the ureteroscope becomes tedious. The wireless console 
decreases surgeon fatigue and osteoarticular pain that may result from the manual 
ureteroscope handling because the ILY robot enables the surgeon to do the surgery from 
a seated position while performing limited hand movements with the remote control. 
Gauhar et al. [15] also noted that placing the robot is easy and quick, taking only 5 mins 
to set up and 3 mins to install. 
One limitation to the ILY, however, is that using a video-game controller forces the 
surgeon to learn how to use the control buttons to replicate the expected flexible 
ureteroscope movement which might be time consuming [15]. 
The ILY® robotic platform has received CE marking which means that it complies with 
the European Union safety, health, and environmental protection standards for medical 
devices [24]. However, it has not yet obtained FDA approval for use in the US. 
5.0- Study Design: 
This study is a parallel group noninferiority trial in the form of a multicenter randomized 
controlled trial with 1:1 allocation in a treatment group (Group 1) and control group 
(Group 2). The treatment group will undergo laser lithotripsy with a robotic flexible URS 
utilizing the ILY® robotic system and the control group will undergo laser lithotripsy 
with manual URS which is the standard of care. 
 
5.1- Participants: 
 
The participating centers will have predefined inclusion and exclusion criteria for patient 
eligibility. Patients presenting to the clinic or emergency department (ED) with renal 
stones requiring laser lithotripsy will be identified by the treating physician (urologist) in 
the corresponding center. Physicians will assess the patient against the inclusion criteria 
and, if deemed eligible, notify a designated member of the research team. 
Once a potential participant is identified, a member of the research team will approach 
them in a private and comfortable setting (urology clinics or PAU to ensure 

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confidentiality. During this interaction, the research team member will explain the 
purpose, procedures, risks, and benefits of the study in detail. Ample time will be 
provided for the patient (or their legal representative, if applicable) to ask questions and 
make an informed decision. 
If the patient agrees to participate, they will be asked to sign an informed written consent 
form. 
The patients will be enrolled prospectively from multiple centers between April 1, 2025, 
to April 30, 2027, or until the target patient recruitment is complete, whichever is earlier. 
The eligibility criteria for including a patient in the study is demonstrated in Table 1. 
 
Table 1: Eligibility Criteria 
Inclusion Criteria 
Exclusion Criteria 
Males or females ≥ 18 years old 
Children < 18 and pregnant women 
Patients with a normal pelvicalyceal 
anatomy 
Patients with anatomically anomalous 
kidneys, known case of stricture or 
stenosis, or recent 3-month history of 
ureteroscopy (DJ stent placement only 
will be accepted) or known history of 
complicated ureteroscopy 
Patients with renal stone diagnosis 
confirmed by non-contrast computed 
tomography regardless of stone size, 
location, and multiplicity 
Patients in whom stone measurement was 
not feasible on NCCT or those with 
concomitant ureteric stones. 
ASA score I-III 
ASA score IV 
Intact mental and cognitive ability to 
provide informed consent and willingness 
to participate in the study with 30-day 
follow-up 
Mentally incapacitated patients unable to 
provide informed consent 
 
Patient data collected will be coded by giving the patients ID numbers. Coded data will 
be shared with the data analysts to minimize the risk of bias. 
 
 

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5.2- Sample Size Calculation:  
 
With a type I error rate of 0.05, power of 0.8, case to control ratio of 1, drop outrate of 
20%, expected proportion of outcome of interest in treatment group (Group 1) of 0.924 vs 
control group (Group 2) of 0.894 [13], and margin on risk difference scale of 0.10, the 
total sample size will be 152 , with 76 in each of the treatment and control groups. The 
expected proportions used in calculating sample size are from the results of a study 
looking at Roboflex Avicenna-assisted (Elmed, Ankara, Turkey) vs classical 
ureteroscopy’s SFR, since there are no studies comparing ILY-assisted to classical 
ureteroscopy’s SFR[14]. Both robots have similar technology, ergonomics, safety profile, 
and operative outcomes. Additionally, both systems have similar procedural workflows 
and surgeon learning curves. 
Considering that the results from the initial prospective clinical assessment of the 
ILY® robotic system done at our center are similar to the results in the aforementioned 
study, we believe the results can be generalized. 
Furthermore, a review of the literature showed the clinically relevant margin on risk 
difference was 8 to 10% and it was deemed that a margin of 10% will be clinically 
relevant for our study[27, 28]. 
5.3- Recruitment Strategies 
1. Multi-Center Recruitment Approach 
 
The study will be conducted at multiple high-volume urology centers to 
maximize patient recruitment and ensure a diverse patient population. 
 
Sites will be selected based on annual case volume of URS (ureteroscopy) and 
robotic kidney stone procedures, ensuring access to eligible participants. 
 
2. Patient Outreach and Education 
 
Patients undergoing preoperative consultation for kidney stone treatment will 
receive detailed study information, including potential benefits and risks of robotic 
vs. manual URS. 
 
Participant Withdrawal: 
Participants may be withdrawn from the study for the following reasons: 
 
 Loss to Follow-Up: If a participant cannot be reached after three 
documented contact attempts, they will be considered lost to follow- up. 

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 
Voluntary Withdrawal: Participants who choose to voluntarily 
withdraw from the study will be removed, and the reason for 
withdrawal should be documented. 
 
Participants who are withdrawn from the study or lost to follow-up will not 
be replaced. Data collected up to the point of participant withdrawal will be 
retained and included in the analysis to ensure study integrity, in accordance 
with ethical guidelines and study protocol. No further data will be collected 
after withdrawal. 
 
5.4- Blinding and Randomization: 
Patients will be blinded as follows: 
1- During the recruitment stage, patients will not be informed about which group they will 
be randomized into. Patients involved in the study are those already planned for surgery 
and eligible for both robot-assisted or manual URS. 
 
The cost of the procedure, whether performed with the ILY robot or manual flexible 
URS, is covered under the same standard package for ureteroscopy. No additional 
charges are applied for robotic use. 
2- During the operation, all equipment will be masked until the patient is under general 
anesthesia to prevent patient knowledge of the procedure type. 
 
3- The physician and operating room (OR) team will not be blinded to the intervention 
because, by the nature of the procedure, they will inherently know which technique is 
being used during the operation. 
 
4- Postoperative care teams cannot be blinded since the operation note will include details 
of the procedure. However, patients involved in the study will be flagged on EPIC to 
ensure procedure details are not disclosed to them. Care teams will be reminded during 
handovers to avoid revealing group allocation. Moreover, postoperative care protocols 
will be standardized to maintain consistency among the groups. 
 
5- During follow-up, patients will receive the same postoperative care instructions 
regardless of the procedure type. 

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6- Regarding outcome assessors, they will be blinded to the group allocation to ensure 
there will be no bias in the evaluation of postoperative outcomes. 
 
Randomization and Allocation Concealment: 
REDCap (Research Electronic Data Capture) will be used to implement a centralized, 
web-based randomization system with built-in allocation concealment and stratification 
by center.A computer-generated randomization sequence for 1:1 allocation will be 
created and maintained by the lead site (AUBMC) using REDCap's randomization 
module. This system will ensure that allocation is concealed until after the participant has 
been enrolled and eligibility confirmed. 
Urology treating physicians at the collaborating centers will have no access to or 
knowledge of the randomization sequence. Once a patient is confirmed eligible and 
consented, the collaborating site will access REDCap, which will automatically assign 
the treatment group based on the pre-generated concealed sequence. This process ensures 
that the person enrolling participants cannot predict or influence assignment. 
Collaborating centers will be given REDCap access limited to their Data Access Groups 
(DAGs). REDCap will be password-protected with access restricted to the team of the 
study. 
 
5.5- Intervention: 
The treatment group will undergo flexible URS with a robotic URS manipulator 
ILY® (Sterlab, Vallarius, France) while the control group will undergo a routine flexible 
ureteroscopy performed manually. Both procedures can be performed under general 
anesthesia and the surgeon can use any scope brand and sheath depending on availability 
on the premises that all scopes used are 7.5 Fr disposable. It will be documented whether 
the sheath used is suction, non-suction, or if no sheath was used. In addition to the 
planned 1:1 allocation of patients in the treatment and control groups. Any laser type can 
be used... 
Any positive urine culture will be treated preoperatively as per the center’s own 
antibiogram/protocol. Any antiplatelet or anticoagulation will be stopped 5 days prior to 
surgery and documented as such. If stopping the antiplatelet or anticoagulation 
medications was not feasible, these patients will be excluded from the study. Any on 
table decisions such as the use of accessories, abandoning procedure, switching to 
another technique due to complications, switching equipment due to malfunction, or 
stenting the patient will be as per surgeons’ discretion and will be documented. If intra-op 

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the stone was amenable to direct basketing without the need for lithotripsy laser, these 
patients will be automatically excluded from the study. 
 
6.0- Study Measures: 
 
Primary Measures: Efficacy will be assessed by measuring the stone-free rate (SFR). A 
patient is considered stone free if there are no visible residual stone fragments after the 
treatment. It will be assessed by an NCCT done at 4 weeks from the index procedure. 
Residual Fragments (RF) will be assessed using a "bone window" setting on the CT 
scan for better accuracy. Strict criteria will be used defining SFR as zero residual 
fragments. 
 
Secondary Measures: 
Safety outcomes will be assessed as perioperative and 30-day postoperative outcomes. 
Clavien-Dindo Classification (26) will be used for adverse events monitoring. This 
assessment will account for any complications related to the patient's clinical condition 
from the procedure through a 4-week postoperative period. The Clavien-Dindo 
classification system, which has been expanded on in Table 3, provides surgeons with a 
common platform for communication and will capture the safety or risks associated with 
each type of URS. 
 
 
Grade 
Description 
 
 
1 
Any deviation from the normal postoperative course without the need for 
pharmacological treatment or surgical, endoscopic and radiological 
interventions. Acceptable therapeutic regimens are drugs as antiemetics, 
antipyretics, analgesics, diuretics and electrolytes and physiotherapy. This 
grade also includes wound infections open at the bedside. 
 
2 
Requiring pharmacological treatment with drugs other than such allowed for 
grade I complications. Blood transfusions, antibiotics and total parenteral 
nutrition are also included. 
3 
Requiring surgical, endoscopic or radiological intervention 
3a 
Intervention under regional/local anesthesia 
3b 
Intervention under general anesthesia 

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4 
Life-threatening complication requiring intensive care/intensive care unit 
management 
4a 
Single organ dysfunction 
4b 
Multi-organ dysfunction 
5 
Patient demise 
Table 3: The Clavien-Dindo classification system 
 
Other secondary measures will be ergonomics, surgeon safety in terms of radiation 
exposure, and intraoperative parameters (operative time, draping time, docking time, 
lasing time, conversion rate, etc..) 
 
The NASA Task Load Index (Figure 1) will be used to assess for ergonomics [29], which 
will be filled by the surgeon after each surgery. This measures workload by assessing 7 
dimensions (e.g., physical demand or effort) using a scale with 21 graduations ranging 
from very low to very high (perfect to failure in the case of performance). Each 
dimension’s scores will be added up in each of the treatment and control groups, 
calculating the mean of each group. Comparative analysis will be conducted between the 
groups on each dimension, as well as on the mean of all dimensions added together, 
which will be considered the workload score. The physical demand dimension will act as 
a subjective measure for ergonomics. 
Figure 1: The NASA Task Load Index 

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Surgeon safety from ionizing radiation will be assessed by the surgeon wearing 3 dosimeter 
badges, one in each of the following: Around their neck, in their chest pocket, and on their 
pants’ waistband to capture radiation exposure near organs that are at risk of malignancy. 
The areas on the body where they will be worn can be seen in Figure 2. The “Instadose” 
dosimeter badges will be used to detect and record exposure. These are small badges easily 
clipped on clothing (refer to figure 3) which function as a wireless dosimetry system 
consisting of three main components: a wireless dosimeter, a communication device (either 
a smart device with the Instadose Companion Mobile App or an InstaLink™3 Gateway), and 
an online reporting system accessed through a PC. The results will be available almost 
immediately by downloading the information on a computer, smartphone or mobile device 
and a comprehensive archive of official dose records will be maintained. 
Two sets of 3 dosimeter badges will be kept in the same locker away from any 
sources of radiation other than background radiation. One set will be used by the surgeon 
exclusively during the treatment group’s procedures, the other set will be used 
exclusively during the control group’s procedures. The devices will be sent weekly to a 
technician to collect the data from the application and extrapolate it onto secured excel 
sheets in a radiation unit of measure, mrem. This will also ensure that any issue with the 
badges or the app will be detected early on and attended to. 
Figure 2: Locations of tonometry badges 
 

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Figure 3: Instadose Wireless Dosimetry System 
 
 
 
 
The Guy’s Stone Score [30] will be used to assess the stones preoperatively and 
determine complexity. Since we are randomizing the patients into two groups, this should 
overcome the potential confounding effect of this variable. It will be included in the 
descriptive statistics section to assess how comparable the final two groups are. If the two 
groups were not balanced, then, this will be explored in the analysis section. Figure 4 [31] 
expands on the Guy’s score which has been validated in multiple studies and is easy to 
apply. Higher Guy’s stone score has been correlated with a lower stone free rate [30]. 
 
Figure 4: The Guy’s Stone Score 
 

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7.0 Schedule of Activities 
 
7.1- Pre-procedure Evaluation 
The following assessments will be done prior to the procedure: 
- Patient demographics 
- Medical/Surgical History 
- NCCT scan which is the standard of care 
- Guy’s stone score 
7.2- Pre-discharge Evaluation 
- Adverse events/Complications 
- Length of hospital stay 
If the subjects experienced prolonged hospitalization post procedure, any further 
assessments performed should be documented in addition to the reason for the extended 
stay. 
7.3- Postoperative Follow Up 
One month after the procedure (30 days) with an acceptable visit time frame of +/- 7 days 
- NCCT scan will be done to assess SFR 
- Adverse events/Complications 
7.4- Unscheduled Follow Up Visits 
If a subject visit occurs outside the protocol-specified time frame (one-month post-op), 
study sites are required to record data from that visit, especially if it is related to the 
procedure itself. 
Possible reasons requiring data collection from the visit include: 
- Subjects experiencing new symptoms and/or an adverse event 
- Follow Up on an adverse event that occurred previously 
 
8.0- Data Analysis and Significance 

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Primary analysis will be performed using an intention to treat (ITT) approach. 
For our primary outcome, we will compare the two groups’ stone free rates using the Chi- 
square test, or Fisher’s exact test if appropriate. The P-value and effects size (Cohen’s h) 
will be reported. Risk ratios with 95% confidence intervals will be calculated for the ILY- 
assisted ureteroscope with the classic approach as the reference group. 0.05 will be set as 
the p-value threshold. 
Perioperative and postoperative complications within 30 days, as per Clavien-Dindo 
classification, will be compared the same way after stratifying the complications into their 
respective Clavien-Dindo group. 
As for the NASA Task Load Index, the overall scores of the two groups will be compared 
using the independent t-test or Mann Whitney U test, according to the normality of the 
results assessed by Shapiro-Wilk test. The mean and 95% confidence intervals of the 
overall scores will be reported, alongside the P-values and effect size (Cohen’s d). 
Individual factor scores within the NASA Task Load Index will be compared similarly. 
Surgeon safety, assessed by radiation exposure rate, as well as other intraoperative 
parameters like operative time, draping time, docking time, lasing time, and conversion 
rate will be compared using the same method. 
Logistic regression will be employed, particularly interaction terms between intervention 
(ILY vs classical approach). This term will be included in the bivariate logistic regression 
of stone free rate and Clavien-Dindo complications. The term will also be used for the 
NASA Task Load Index scores and radiation exposure rate, in the context of linear 
regression. 
Since stratification by laser type is not` performed at randomization, we will adjust for laser 
type as a covariate in all primary and secondary outcome analyses to control for potential 
confounding. 
Regarding missing data, if the proportion is small, we will use complete case analysis 
where only participants with complete data are analyzed. 
If the missing data comprises a big proportion, a systematic approach will be utilized 
through multiple imputations particularly for ergonomics and surgeon safety assessments. 
In addition, sensitivity analysis will be conducted to assess the impact of the missing data 
on the results. 
 
The ILY robotic system represents technological advancement in the field of URS. There 

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is currently no noninferiority randomized controlled trial (RCT) comparing the ILY robot 
to manual flexible URS. This proposal addresses a significant gap by evaluating whether 
robotic assistance can provide equivalent or superior efficacy and safety, improving 
clinical outcomes, procedural consistency, and surgeon ergonomics and radiation 
exposure. 
The successful completion of this study could have a significant impact on urological 
practice encouraging the adoption of the ILY robot in routine kidney stone management, 
potentially improving the standard of care. 
In terms of methodology, the proposed RCT using the noninferiority design will yield 
key metrics including stone-free rate, peri and post-operative outcomes, ergonomics, 
surgeon safety in terms of radiation exposure, and intraoperative parameters. The trial 
will be conducted with strict randomization, blinding of outcome assessors, and adequate 
sample size calculations to ensure robust statistical power. 
 
9.0- Maintaining Records 
The study sponsor (AUBMC) will maintain hard and electronic copies of the data 
collected from the centers including the consent forms, adverse events, and other records 
related to the trial. Clinical sites will maintain study records for a minimum of 3 years 
after study completion. 
The study investigators will maintain all relevant study documentation through entering 
the data into a secure electronic database (REDCap). Personal identifiers will be hidden, 
and the data will be labeled according to the Medical Record Number (MRN) of each 
patient to protect their identity and personal information. Each patient will be also given a 
study ID number. The coded data set will be provided to the statistician for analysis and 
the data will be analyzed and reported in that form. We will maintain an excel sheet with 
the Patient Name, MRN, and assigned Code to allow re-identification if necessary (for 
follow-up). This version will only be accessible by the local PI and will be secured and 
stored in a separate file on the computer of the PI with strong passwords to maintain 
access control and confidentiality. 
 
The final trial dataset will be accessible only to the principal investigators and authorized 
research personnel at AUBMC. Collaborating centers will not have access to the full 
dataset. Data sharing is governed by institutional policies and ethical guidelines to ensure 
compliance with data protection regulations. 
 

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10.0- Adverse Events and Safety Monitoring 
As discussed before, the ILY robot has a strong safety profile observed in the first two 
prospective clinical assessments done by Hajj et al. and Farre et al. This is why this study 
does not carry any additional risk on the patients and, therefore, we expect a low 
incidence of adverse events. 
 
1. General Anesthesia 
Both procedures require the same standard of general anesthesia for ureteroscopy. 
2. Risks Specific to Manual Flexible Ureteroscopy (Standard of Care) 
The known procedural risks include: 
 
Ureteral injury 
 
Infection or sepsis 
 
Hematuria 
3. Risks Specific to Robot-Assisted Lithotripsy (ILY Robotic System) 
Mechanical malfunction of the robotic system, although rare, could require conversion to manual 
ureteroscopy intraoperatively. This will have no impact on the patient. 
At present, no evidence suggests that the ILY system increases overall risk 
compared to manual fURS, and preliminary studies have shown comparable safety 
profiles [24]. 
In case of any adverse events, prompt investigations will be done, and appropriate 
treatment plans will be implemented based on the standards of care. 
Additionally, all equipment used will be routinely checked by the medical 
engineering department as per standard protocols. Also, before each procedure the 
OR nursing team will check the equipment as per standard practice. 
 
Plan for Handling Unexpected Intraoperative Events and Device Malfunctions 
During the Trial: 
Common Intraoperative Complications: 
1. Ureteral or Renal Pelvis Perforation 
o Step 1: Stop the procedure and assess severity using imaging if necessary. 

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o Step 2: Place a ureteral stent or nephrostomy tube to divert urine and allow 
healing. 
o Step 3: Postpone further intervention if clinically indicated. 
o Step 4: Document and report to the trial coordination team. 
Postoperative care: 
Monitor with follow-up contrast imaging to confirm resolution. 
2. Bleeding or Hematuria 
Intraoperative management: 
- Apply gentle irrigation to clear the field and identify the source of bleeding. 
- If bleeding is localized, use tamponade with the ureteroscope or reduce laser 
power. 
- Stop the procedure if bleeding is uncontrolled and ensure hemostasis. 
Postoperative care: 
Monitor hematuria and provide supportive care (e.g., hydration). 
3. Stone Migration 
Intraoperative management: 
- Retrieve migrated fragments during the same procedure if possible. 
- If inaccessible, schedule a follow-up procedure. 
Postoperative care: 
- Use follow-up imaging to monitor residual stones and schedule additional 
interventions if necessary. 
4. Scope Damage 
Intraoperative management: 
- If the scope fails, switch to a backup device. 
- Document the incident for follow-up maintenance or manufacturer feedback. 
5. Device malfunctions: 
o Step 1: Pause the procedure and attempt to troubleshoot using the provided 
user manual. 

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o Step 2: Notify the OR team and assess the patient's condition. 
o Step 3: If unresolved within 10 minutes, convert to manual fURS or 
alternative method. 
o Step 4: Document the issue and notify the trial coordination team. 
Documentation and Reporting: 
There should be immediate documentation of any intraoperative event, including: 
 
Nature of the event. 
 
Steps taken to manage it. 
 
Outcome (e.g., resolved, conversion to another method). 
o All events must be reported to the central trial coordinating team within 24 
hours for review and analysis. 
Post-Event Follow-Up 
Patient Monitoring: 
- Monitor the patients postoperatively and manage any complications according to 
the standards of practice. 
To ensure that the same procedures are followed at all participating centers, a 
standardized and systematic approach will be implemented: 
1. Standardized Protocols: 
o All study centers will follow a single, unified protocol that has been 
approved by the IRB at AUBMC. 
2. Regular Communication and Monitoring: 
o AUBMC’s study coordinator will oversee recruitment and adherence to 
protocols, acting as the main point of contact for any site-related queries. 
3. Data Collection and Quality Control: 
o All data will be collected on RedCap. 
o The postdoctoral research fellows of Dr. Albert El Hajj will conduct remote 
monitoring for the data collection to ensure compliance with the protocol. 

22
 
This is feasible through checking the data on RedCap monthly to assess 
data entry progress, missing fields, and data inconsistencies. 
4. Data and Safety Monitoring Board (DSMB): 
A DSMB will be established to oversee patient safety and the integrity of 
the study as mentioned in the protocol. The DSMB will be responsible for 
reviewing the data about the procedures and adverse events to ensure the 
safety of the subjects. It will also monitor adherence to ethical standards 
and trial conduct. This committee will be independent from the study 
investigators and will meet bi-annually. 
The following members will form the DSMB: 
1- Dr. Bassel Bachir, MD 
Department of Surgery, Division of Urology, American University of Beirut Medical 
Center, Beirut, Lebanon 
2- Dr. Marlene Chakhtoura, MD 
Department of Internal Medicine, Division of Endocrinology, American University of 
Beirut Medical Center, Beirut, Lebanon. 
3- Dr. Marianne Majdalani, MD 
Division of Pediatric Intensive Care Vice-chair, Bioethics and Professionalism Program, 
American University of Beirut Medical Center, Beirut, Lebanon. 
 
A uniform protocol will be shared with all centers for adverse event reporting and 
managing withdrawals. 
11.0- Ethical Considerations and Dissemination 
11.1- Ethical Considerations: 
- This study will be conducted following the principles of Belmont Report and 
abiding by the principles of responsible research conduct and scientific integrity. 
-  Approval from AUBMC’s Institutional Review Board will be sought, with regular 
audits taking place throughout the trial. Findings from these audits will be 
documented, and any necessary corrective actions will be implemented promptly. 
- Written informed consent will be obtained from all the participants. 
- Any modifications to the study protocol will be submitted for approval by the 
Institutional Review Board (IRB) prior to implementation. All approved changes 
will be promptly communicated to the collaborating centers and investigators to 
ensure compliance with the updated protocol. 
- Regular progress reports will be submitted to the IRB according to their 
established guidelines. Upon completion of study, the IRB will be notified. 

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11.2- Data Sharing Plan: 
 
Coded participant data, including baseline characteristics, primary and secondary outcome 
measures, and statistical analysis plans will be made available upon reasonable request from the 
corresponding author, beginning six months after publication and ending five years after the 
publication date, ensuring compliance with ethical guidelines and institutional review board 
(IRB) regulations. 
 
The study protocol, statistical analysis plan, and informed consent forms will also be accessible 
upon request. Researchers seeking data must submit a methodologically sound proposal, which 
will be reviewed by the trial steering committee. Data will be shared in compliance with 
institutional and ethical regulations. 
To facilitate data reproducibility and secondary analyses, study protocols, statistical analysis 
plans, and consent forms will also be accessible via [institutional repository or corresponding 
author]. Researchers requesting access must submit a formal proposal, which will be reviewed 
by the study steering committee. 
 
12.0- Conflicts of Interest 
The authors declare there are no conflicts of interest related to this study. Neither the 
manufacturer nor any affiliated company of the ILY Robot had any role in the study 
design, data collection, analysis, interpretation, manuscript preparation, or decision to 
publish the results. No financial or non-financial support, including grants, was received 
from the manufacturer. 

24
 
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