Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Sponsor: PROCEPT BioRobotics

 
 
 
PROCEPT BioRobotics Corporation  ·  900 Island Drive, Suite 101  ·  Redwood City, California 94065 
 
office: +1.650.232.7200  ·  Fax: +1. 650.232.5782  ·  info@PROCEPT-BioRobotics.com 
 
 
 
 
 
 
Official Title:  
WATER II 
Waterjet Ablation Therapy for Endoscopic 
Resection of prostate tissue II  
Clinical Investigational Protocol 
NCT Number:  
NCT0312350 
Document Date:  
22-January-2020 
 

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WATER II 
Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue II 
 
Protocol Number: 
 
Version Number: 
 
Date: 
TP0124 
 
C  
 
22 January 2020 
Device: 
AQUABEAM® System  
Commercial 
Sponsor: 
PROCEPT BioRobotics Corporation 
900 Island Drive, Suite 101 
Redwood City, CA 94065, USA 
Geographical 
Region: 
United States and Canada 
 
 
 
 
 
 
Protocol Revision Number 
Protocol Revision Date 
Rev. A 
11 April 2017 
Rev. B 
31 May 2019 
Rev. C 
22 January 2020 
 
 
 
Confidential and Proprietary 
This study plan contains confidential and proprietary information provided by PROCEPT BioRobotics 
Corp. to each Investigator in this clinical trial.  This information is intended for review and use by the 
Investigator, his/her staff, and the Ethics Committee and is not to be disclosed to others without the 
written permission of PROCEPT BioRobotics Corp. 
 

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1 GENERAL STUDY INFORMATION 
1.1 Study Acknowledgement/Confidentiality  
By signing this Protocol, the Investigator(s) acknowledges and agrees: 
The WATER II study will be conducted according to the IRB approved protocol and in accordance 
with 21 CFR 50, 54, 56, 812 and any other applicable regulations. The Protocol contains all 
necessary details for conducting the study. The Investigator will conduct this study as detailed 
herein, in compliance with The World Medical Association Declaration of Helsinki (59thWMA 
General Assembly, Seoul, October 2008) and the applicable regulatory requirements, and will make 
every reasonable effort to complete the study within the time designated. 
The Protocol and all relevant information on the device relating to pre-clinical and prior clinical 
experience will be made available to all physicians and other personnel who participate in 
conducting this study.  The Investigator will discuss this material with the study team to ensure that 
they are fully informed regarding the device and the conduct of the study. 
This document contains information that is privileged or confidential.  As such, it may not be 
disclosed unless specific prior permission is granted in writing by both the sponsor and principal 
investigator or such disclosure is required by laws.  Persons to whom any of this information is to 
be disclosed must first be informed that the information is confidential.  These restrictions on 
disclosure will apply equally to all future information supplied, which is indicated as privileged or 
confidential. 
The sponsor and trial participants (including the principal investigator) agree to the terms outlined 
in the attached Clinical Trial Agreement. 
 
Study Role 
Signature 
Date 
(dd/mmm/yyyy) 
Sponsor/Designee 
 
 
Principal Investigator 
 
 
Co-Investigator 
 
 
Co-Investigator 
 
 
Co-Investigator 
 
 
 
 

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1.2 Study Summary 
Title: 
Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue 
II (WATER II) 
Design: 
Pivotal study to support marketing claims, single-arm, interventional 
clinical trial collecting patient data from use of the AQUABEAM System 
Device Name  
and Intended Use: 
PROCEPT BioRobotics has developed the AQUABEAM, a personalized 
image-guided waterjet resection system that utilizes a high-velocity 
saline stream to resect and remove prostate tissue in males suffering 
from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic 
Hyperplasia (BPH) 
Primary Safety 
Endpoint: 
The primary safety endpoint is the proportion of subjects with adverse 
events rated as probably or definitely related to the study procedure 
classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event 
resulting in persistent disability (e.g. ejaculatory disorder or erectile 
dysfunction) evidenced through 3 months post treatment 
Primary 
Effectiveness  
Endpoint: 
IPSS score change from baseline to 3 months 
Enrollment: 
101 participants who received study treatment under protocol rev. A 
Clinical Sites:  
Sixteen (16) clinical study centers (13 in the United States, and 3 in 
Canada) 
Follow up 
Schedule: 
Baseline, Discharge, 1, 3, 6, 12, 24, 36, 48, and 60 months 
Target Population: Men with lower urinary tract symptoms due to BPH resulting from a 
large prostate size (80-150 mL) 
Sponsor: 
PROCEPT BioRobotics Corporation 
900 Island Drive, Suite 101 
Redwood City, CA 94065, USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1 
GENERAL STUDY INFORMATION .................................................................................. 2 
1.1 
Study Acknowledgement/Confidentiality .............................................................................. 2 
1.2 
Study Summary ...................................................................................................................... 3 
2 
STUDY PLAN.......................................................................................................................... 6 
2.1 
Background ............................................................................................................................ 6 
2.2 
AQUABEAM System Clinical Experience Outside of US ....................................................... 6 
2.3 
AQUABEAM System Clinical Experience Within US ............................................................ 7 
2.4 
AQUABEAM System Description ........................................................................................... 8 
2.5 
Regulatory Status ................................................................................................................. 13 
2.6 
Indications for Use ............................................................................................................... 13 
2.7 
Overall Design ..................................................................................................................... 13 
2.8 
Study Objectives .................................................................................................................. 13 
2.9 
Study Duration ..................................................................................................................... 14 
2.10 Number of Sites ................................................................................................................... 14 
2.11 Sample Size .......................................................................................................................... 14 
2.12 Study Population .................................................................................................................. 14 
2.13 Screening and Baseline ........................................................................................................ 15 
2.14 Surgical Procedure ............................................................................................................... 15 
2.15 Preoperative Instructions ...................................................................................................... 16 
2.16 Anesthesia ............................................................................................................................ 16 
2.17 Device Usage and Malfunction Reporting ........................................................................... 16 
2.18 Post-Procedure Management ............................................................................................... 16 
2.19 Study Assessments ............................................................................................................... 17 
2.20 Adverse events ..................................................................................................................... 18 
2.21 Study Withdrawal ................................................................................................................ 20 
2.22 Lost to Follow-Up ................................................................................................................ 21 
2.23 Study Termination ................................................................................................................ 21 
2.24 Case Report Forms (CRF) .................................................................................................... 21 
2.25 Study Exit ............................................................................................................................. 21 
3 
STUDY ENDPOINTS ........................................................................................................... 21 
3.1 
Primary Efficacy Endpoint ................................................................................................... 21 
3.2 
Primary Safety Endpoint ...................................................................................................... 21 
3.3 
Secondary Endpoints for Marketing Claims ........................................................................ 21 
3.4 
Additional Endpoints ........................................................................................................... 22 
4 
STATISTICAL ANALYSIS ................................................................................................. 22 
4.1 
General Approach ................................................................................................................ 22 
4.2 
Primary Endpoint Calculation and Sample Size Determination .......................................... 22 
5 
RISK/BENEFIT ANALYSIS ............................................................................................... 23 
5.1 
Potential Benefits ................................................................................................................. 23 
5.2 
Potential Risks ...................................................................................................................... 23 
5.3 
Risk Mitigation .................................................................................................................... 24 
6 
STUDY ADMINISTRATION .............................................................................................. 24 
6.1 
Clinical Events Committee .................................................................................................. 24 
6.2 
Data Monitoring Committee ................................................................................................ 24 
6.3 
Data Collection/Electronic Case Report Forms (e-CRF) ..................................................... 25 
6.4 
Clinical Monitoring .............................................................................................................. 25 

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7 
STUDY REPORT AND PUBLICATION STRATEGY .................................................... 26 
7.1 
Final Study Report ............................................................................................................... 26 
7.2 
Publication Strategy ............................................................................................................. 26 
8 
BIBLIOGRAPHY ................................................................................................................. 27 
 
 

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2 STUDY PLAN 
2.1 Background 
Benign prostatic hyperplasia (BPH), or enlargement of the prostate due to benign growth of 
glandular tissue, is a very common disease of older men. Prostatic tissue may compress the urethral 
canal, causing partial or sometimes complete obstruction of the prostatic urethra, which interferes 
with the normal flow of urine. Symptoms of BPH include urinary hesitancy, frequent urination, 
dysuria, increased risk of urinary tract infections, and urinary retention. 
Therapy for BPH includes medication and various surgical approaches. While medication is first-
line therapy, many men do not have adequate responses to treatment. Surgical approaches include 
transurethral resection of the prostate (TURP) and other less invasive approaches such as 
transurethral microwave thermotherapy (TUMT) or transurethral needle ablation (TUNA). TURP 
involves invasive removal of prostate tissue using electrocautery and/or sharp dissection. While 
TURP remains the gold standard for surgical treatment, it carries risks, including bleeding, clot 
retention/colic, bladder wall injury, hyponatremia (water intoxication), bladder neck contracture, 
urinary incontinence, retrograde ejaculation, and erectile dysfunction. Additional techniques using 
lasers or electrocautery that either ablate or enucleate the adenomatous tissues have been developed 
to improve the efficiency and reduce the morbidity of TURP. 
2.2 AQUABEAM System Clinical Experience Outside of US 
Eighty-four subjects (New Zealand, Australia and India) have been treated with the AQUABEAM 
System from two clinical trials (APS, N=37; ABS, N=47). 
APS (AQUABEAM Pilot Study) is a prospective multicenter phase II single-arm clinical trial (n=37) 
conducted in India, Australia, and New Zealand. Device generations 1.0 and 1.6 were used. 
Treatment took place between January 2013 and July 2014. The results from this study provided 
early evidence to support the safety and effectiveness of Aquablation for symptomatic benign 
prostatic hyperplasia. 
ABS (AQUABEAM Study) is a single center prospective trial (n=47) with 1-year follow-up in India 
using generation 2.0, 2.1, and 2.2. Treatment took place between December 2014 and October 
2015. This study confirmed procedure process improvements resulting from system enhancements, 
with preservation of safety and effectiveness during use of a second-generation device for the 
treatment of LUTS attributable to BPH. 
In both trials, participants were men aged 50-80 years with moderate-to-severe lower urinary tract 
symptoms as determined by urodynamics. All patients underwent Aquablation under image 
guidance. Primary endpoints included procedural and peri-operative safety. The main clinical 
endpoint was change from baseline in International Prostate Symptom Score (IPSS). Other 
secondary endpoints included uroflow measures, prostate volume by transrectal ultrasound, and 
detrusor pressure (Pdet@Qmax, measured at 6 months only). 
Eighty-four subjects enrolled and underwent Aquablation between January 2013 and October 2015. 
Most procedures were done under general anesthesia; some procedures in India were done under 
spinal anesthesia. The average subject 67.7 ± 6.7 years old with a prostate size of 49.8 ± 22.5 mL 
(range 20-118 mL) with 51.8% having a median lobe. 9 subjects (11%) had a prostate size >80 mL. 

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All procedures were technically successful with a mean ablation time of 5 minutes.  One subject 
required transfusion. None required intravenous electrolyte management. 
A safety summary of the 84 subjects resulted in no adverse events of urinary incontinence, erectile 
dysfunction, or retrograde ejaculation reported. The rates of all other adverse events were 
anticipated with a rate within the range observed with other minimally invasive BPH therapies. 
There were no reported serious adverse events related to the AQUABEAM System.  The efficacy 
results are shown in Figure 1 illustrating changes in IPSS, IPSS quality of life (QOL) score, 
maximum urinary flow rate (Qmax), and post-void residual (PVR). 
 
Figure 1 Twelve months IPSS, Qmax, QoL, and PVR results (mean±SE) 
 
The AQUABEAM System offers the ability to rapidly ablate the adenomatous elements and as 
confirmed by the early clinical experience, the mechanism of action, controlled delivery of high-
velocity saline stream, will potentially reduce complications including sexual dysfunction and 
result in an effective and rapid treatment option for patients with symptomatic BPH. 
2.3 AQUABEAM System Clinical Experience Within US 
WATER (NCT02505919) is a prospective double-blind multicenter randomized clinical trial 
conducted in the US and other sites. Currently, the study enrollment is completed and all subjects 
are in active follow-up. The study was being run under the guidance of a data monitoring committee 
(DMC). The DMC did not recommend any changes to study conduct or endpoints up to DMC 
closure. The trial was reported to FDA to support the De Novo submission which was granted on 
December 21st, 2017 (DEN170024). 

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2.4 AQUABEAM System Description 
The AQUABEAM System is comprised of nine main components along with accessories. The main 
components are as follows: 
 
Figure 2 AQUABEAM System (TRUS Articulating Arm is not shown in this figure) 
 
• AQUABEAM Conformal Planning Unit (CPU) 
Live transrectal ultrasound (TRUS) video are imported into and displayed by the CPU (Figure 3) 
allowing the operator to map the contour of the prostate. The prostatic capsule, verumontanum, and 
bladder are visualized allowing the operating physician to identify key anatomical markers, to 
optimize position of the AQUABEAM Handpiece and select the target area for treatment. 
The planned parameters are downloaded to the AQUABEAM Console and Aquablation treatment 
can be initiated. During Aquablation treatment, the operating physician will utilize the CPU to 
monitor the progress of resection. At any point in time the operating physician can pause 
Aquablation treatment and make real-time adjustments to the target area as appropriate. 
 
 
Figure 3 AQUABEAM Conformal Planning Unit 
(Refer to User Manual for current configuration of the CPU interface) 
 

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• AQUABEAM CONSOLE 
The AQUABEAM Console (Figure 4) is a reusable component of the AQUABEAM System and it 
controls the functionality of the high pressure waterjet delivered by the Handpiece. The Console 
performs the following functions: 
• 
Provides power sources to the CPU, Motorpack, and Foot Pedal 
• 
Controls pump power and speed 
• 
Primes the Handpiece during system setup 
• 
Accepts planned resection angles and treatment profile from the CPU to allow the initiation of 
the Aquablation procedure 
• 
Displays the status of the Aquablation procedure modes (i.e. PLAN or CUT) 
• 
Displays pump level during the Aquablation procedure 
The Console is mounted on the Roll Stand, which is then locked in place to prevent movement 
during the procedure. It is connected to a source of AC power via a transformer with a medical-
grade grounded power cord. It is connected to the CPU via a USB cable and connected to the 
Motorpack and Foot Pedal through custom cables. 
Prior to initiation of Aquablation treatment, the Console is attached to the AQUABEAM Handpiece 
providing the conduit for the saline fluid connection to be used in the subject treatment.  The 
Console generates the saline pressure allowing controlled resection of the prostatic tissue in 
accordance with the AQUABEAM Conformal Planning Unit measurements. In addition, the console 
utilizes a peristaltic pump that assists in evacuation of saline from the bladder and prostatic urethra. 
 
Figure 4 AQUABEAM Console 
(Refer to User Manual for current configuration of the Console) 
• AQUABEAM HANDPIECE 
The AQUABEAM Handpiece (Figure 5) is a sterile single use component of the AQUABEAM 
System.  It obtains it power source and functional commands from the Motorpack. The AQUABEAM 
Handpiece is compatible with the AQUABEAM Scope, which is inserted into the central lumen of 
the Handpiece, enabling live cystoscopic visualization of the prostatic urethra and bladder during 
insertion and Aquablation treatment. 
The tip of the Handpiece is inserted transurethral into the subject and advanced through the prostatic 
urethra into the bladder. Using both live TRUS and cystoscopic guidance, the operating physician 
positions the tip of the Handpiece to the desired location. Upon initiation of Aquablation treatment, 
the high-pressure sterile saline stream exits the AQUABEAM Handpiece tip at a 90o angle to the 
target prostatic tissue. The depth and angle of resection is based on the transferred planned contour 
and profile from the CPU to the Console. 

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Figure 5 AQUABEAM Handpiece 
(Refer to User Manual for current configurations of Handpiece) 
 
• AQUABEAM MOTORPACK 
The Motorpack (Figure 6) is a re-usable component of the AQUABEAM System designed to dock 
with the disposable Handpiece and to move the Handpiece probe both rotationally and 
longitudinally by means of DC motors through a mechanical linkage. “Docking” means the 
electrical connectors and mechanical shafts of both lateral and radial motors in the Motorpack are 
positively engaged with the Handpiece. When complete, a LED on the Console gives a visual 
indication of successful docking.  The Motorpack additionally has user controls consisting of two 
momentary switches, Power Increase Button and Power Decrease Button that signals the system to 
increment or decrement the High Pressure Pump power when pressed. 
The Motorpack is connected to the Console with a flexible cable that carries DC power to the 
Motorpack as well as serial communication lines to transmit Console commands to the 
Motorpack/Handpiece assembly as well as to receive status and control information in return. 
 
Figure 6 AQUABEAM Motorpack 
(Refer to User Manual for current configurations of Motorpack) 
 
• AQUABEAM SCOPE 
The AQUABEAM Scope (Figure 7) consists of a semi-flexible stainless steel hypotube at the distal 
end (indirect patient contact) and a flexible Pebax sheath (non-patient contact), which is connected 
to a proximal eye piece.  The semi-flexible and flexible portions of the Scope are connected by a 
stainless steel adapter.  The Scope has no lumens, ports, or open channels.  The Scope also includes 
3 light adapters, one of which is used, depending upon the light source. 
Prior to initiation of Aquablation procedure, the AQUABEAM Scope is inserted into the central 
lumen of the AQUABEAM Handpiece enabling direct visualization within the prostatic urethra 
during treatment.   
1. 
Motorpack Magnetic Strike Plate for Handpiece 
Articulating Arm 
2. 
Pump Power Control Buttons (+/-) 

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The Scope camera is positioned just proximal to the AQUABEAM Handpiece tip to visualize the 
treatment zone. Cystoscopic imaging is used in conjunction with TRUS to monitor progression of 
tissue resection. 
 
Figure 7 AQUABEAM Scope 
(Refer to User Manual for current configurations of Scope) 
 
• AQUABEAM FOOT PEDAL 
The AQUABEAM Foot Pedal (Figure 8) contains three foot-activated momentary switches. It is 
connected to the Console with a flexible cable.  The Aquablate Pedal is the large center switch 
which must be depressed to enable Aquablation.  The Aquablate Pedal is also used in the centering 
the of the Handpiece probe during the planning process.  The two smaller switches at top left and 
top right provide controls to manual aspiration and manual priming. 
 
Figure 8 AQUABEAM Foot Pedal 
(Refer to User Manual for current configurations of Foot Pedal) 
 
• AQUABEAM ROLL STAND 
The AQUABEAM Roll Stand (Figure 9) is the main power source to the Console and serves as the 
chasis for the AQUABEAM System.  The Roll Stand performs the following functions: 
• 
AQUABEAM pump supply saline bag mount 
• 
Adjustable CPU mount 
• 
Console shelf 
• 
Tissue collection container holder 
• 
Articulating Arms storage rail (TRUS and Handpiece) 
• 
Adjustable keyboard mount 
• 
Foot pedal storage mount 
• 
Serves as the storage unit for the AQUABEAM System 
Aquablation 

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The power cable of the Roll Stand is plugged into the power outlet in the surgical suite or operation 
room to supply power to the Console. 
The keyboard is the user data input to the CPU. 
 
Figure 9 AQUABEAM Roll Stand 
(Refer to User Manual for current configurations of Roll Stand) 
 
• AQUABEAM HANDPIECE ARTICULATING ARM 
The AQUABEAM Handpiece Articulating Arm (Figure 10) fixes the Handpiece and Motorpack in 
position relative to the patient. The Handpiece Articulating Arm performs the following functions: 
• 
Connects to standard bedrails 
• 
Allows full freedom movement when Release Trigger is depressed 
• 
Locks rigidly when Release Trigger is not depressed 
• 
Connects to Motorpack/Handpiece via defeatable magnetic latch 
• 
Allows ±20° of Handpiece rotation with 2°discrete locking points 
• 
Provides bubble level to visualize horizontal plane 
• 
Provides stability of Handpiece during Aquablation 
 
 
 
1. 
Handpiece Articulating Arm 
 
2. 
Bedrail Clamp 
 
3. 
Magnetic Latch Block 
 
4. 
Articulation Release 
Figure 10 Handpiece Articulating Arm 
(Refer to User Manual for current configurations of Handpiece Articulating Arm) 
 
 

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• AQUABEAM TRUS ARTICULATING ARM 
The AQUABEAM TRUS Articulating Arm (Figure 11) fixes the TRUS probe and stepper in position 
relative to the patient.  The TRUS Articulating Arm performs the following functions: 
• 
Connects to standard bedrails 
• 
Allows full freedom movement when Release Trigger is depressed 
• 
Locks rigidly when Release Trigger is not depressed 
• 
Connects to TRUS probe and stepper 
• 
Provides stability of TRUS probe during Aquablation 
 
Figure 11 TRUS Articulating Arm 
(Refer to User Manual for current configurations of TRUS Articulating Arm) 
2.5 Regulatory Status 
The AQUABEAM System received US FDA De Novo grant on December 21st, 2017 (DEN170024) 
and concluded that the device should be classified into Class II. It is CE marked in Europe and 
currently commercialized in Australia, New Zealand, Canada, the United States, and select 
European markets. 
2.6 Indications for Use 
The AQUABEAM System is intended for the resection and removal of prostate tissue in males 
suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia. 
2.7 Overall Design 
Pivotal study to support marketing claims, single-arm, interventional clinical trial collecting data 
from the use with the AQUABEAM System. 
2.8 Study Objectives 
The primary endpoint of this study is to evaluate the efficacy of the AQUABEAM System for the 
treatment of lower urinary tract symptoms resulting from BPH, as measured by the changed in IPSS 
score at 3 months. 
 
 

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2.9 Study Duration 
Each subject is followed postoperatively through 60 months. Total study duration from first subject 
enrolled to last subject completing the 60 months follow-up visit is expected to take approximately 
six years. 
2.10 Number of Sites 
Sixteen (16) clinical sites will participate, 13 in the United States, and 3 in Canada. 
2.11 Sample Size 
One hundred and one (101) participants who received study treatment under protocol rev. A. 
2.12 Study Population 
Men with lower urinary tract symptoms due to BPH resulting from a large prostate size (80-150 
mL). To participate, a patient must meet all inclusion criteria and none of the exclusion criteria 
listed in Table 1. 
Table 1 Study Eligibility Criteria 
Inclusion Criteria 
a) Male age 45-80 years 
b) Subject has diagnosis of lower 
urinary tract symptoms due to 
benign 
prostatic 
enlargement 
causing bladder outlet obstruction 
c) Subject has an IPSS score greater 
than or equal to 12 
d) Maximum 
urinary 
flow 
rate 
(Qmax) less than 15mL/s1 
e) Serum creatinine < 2 mg/dL 
within 30 days of surgery 
f) History of inadequate or failed 
response, 
contraindication, 
or 
refusal to medical therapy 
g) Prostate size ≥ 80 mL and ≤ 150 
mL as measured by TRUS 
h) Patient is mentally capable and 
willing to sign a study-specific 
informed consent form 
Exclusion Criteria 
a) BMI ≥ 42 
b) Patients unable to stop anticoagulants, antiplatelet 
agents, or non-steroidal anti-inflammatory agents 
(NSAIDs, including aspirin greater or equal to 
100mg) prior to treatment per standard of care 
c) History of gross haematuria 
d) Participants using systemic immune-suppressants 
including corticosteroids (except inhalants); unable 
to withhold non-steroidal anti-inflammatory agents 
(NSAIDs, including aspirin) prior to treatment per 
standard or care except for low dose aspirin (e.g. 
less than or equal to 100mg) 
e) Known coagulopathy or platelet disorder  
f) Contraindication to both general and spinal 
anesthesia 
g) Any severe illness that would prevent complete 
study participation or confound study results 
h) History of prostate cancer or current/suspected 
bladder cancer. Prostate cancer should be ruled out 
before participation to the satisfaction of the 
investigator if PSA is above acceptable thresholds  
i) History of actively treated bladder cancer within 
the past two (2) years  
j) Diagnosis of polyneuropathy  
k) Clinically significant bladder calculus or bladder 
diverticulum (e.g., pouch size >20% of full bladder 
size)  
l) Active infection, including urinary tract infection 
or prostatitis  

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m) Urinary catheter use daily for 90 or more days 
consecutively 
n) Previous urinary tract surgery such as e.g. urinary 
diversion, artificial urinary sphincter or penile 
prosthesis 
o) Diagnosis of or has received treatment for chronic 
pelvic pain syndrome 
p) Ever been diagnosed with a clinically significant 
urethral stricture or meatal stenosis, or bladder 
neck contracture  
q) Known damage to external urinary sphincter  
r) Has had an open heart surgery, or cardiac arrest < 
180 days prior to the date of informed consent  
s) Known illicit substance abuse  
t) Participants using anticholinergics specifically for 
bladder problems. Use of medications with 
anticholinergic properties is allowable provided the 
patient does not have documented adverse urinary 
side effects from these medications.  
u) Dementia or psychiatric condition that prevents the 
participant from completing required follow up  
v) Previous pelvic radiotherapy  
w) Participating in another investigational study that 
could affect responses to the study device  
x) Subject is unwilling to accept a transfusion should 
one be required  
1The total voided volume must be ≥ 125mL.  If the total voided volume is less than 125mL, the voided volume must be equal to or 
greater than 50% of the bladder capacity (defined as voided volume + PVR).  The patient can repeat the test if necessary. 
2.13 Screening and Baseline 
Potential study participants will undergo screening at the study center. A patient must sign a study-
specific, IRB approved informed consent form prior to any baseline testing for eligibility that goes 
beyond standard care. Each patient will be assigned a study ID after signing the informed consent 
form. 
Baseline assessment consists of the tests listed below. Please refer to Table 2 for detailed test list 
and requirement: 
• 
Medical history focusing on urinary symptoms 
• 
Uroflowmetry for Qmax and PVR 
• 
Transrectal Ultrasound (TRUS) for measuring prostate volume 
• 
Questionnaires for assessing BPH symptoms and sexual functions (see schedule of 
assessments) 
• 
Concomitant medications 
• 
Blood tests (see schedule of assessments) 
2.14 Surgical Procedure 
The surgical procedure should take place within 90 days of baseline tests. 

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2.15 Preoperative Instructions 
Patients must avoid taking non-steroidal anti-inflammatory agents (NSAIDs) or antiplatelet agents 
(e.g., aspirin, clopidogrel) prior to surgery per standard of care. 
2.16 Anesthesia 
All surgical procedures will be performed under general or spinal anesthesia. 
2.17 Device Usage and Malfunction Reporting 
A brief description of use of the AQUABEAM System is provided below. The study investigator will 
be trained in device use through didactic, practicum training and proctoring. Complete details on 
the preparation and use of the AQUABEAM System can be found in the device’s instructions for use 
and user manual documents.  Should any device defect or malfunction be noticed at any point, 
whether prior to, during, or after a procedure, this defect or malfunction will be reported through 
PROCEPT’s standard medical device reporting process. 
AQUABEAM Device Use. The AQUABEAM device will be used according to the manufacturer’s 
instructions for use. The Handpiece is removed from the urethra and the Investigator uses a balloon 
catheter inflated in the prostatic fossa for approximately 3-5 hours to achieve adequate hemostasis. 
Analysis of Excised Tissue. Histopathology of the excised tissue will be performed.  The study 
sponsor will be allowed access to the high-definition photographs of the tissue slides. 
2.18 Post-Procedure Management 
Post-procedure care is defined as care provided to the subject during the period starting after the 
procedure to hospital discharge. The subject will be managed post-operatively and discharged as 
per standard practices. At 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 
months, and 60 months the subject will return for follow up visits. The 60 months visit concludes 
the subject’s participation in the study.  Please refer to Table 2 for detailed test list and requirement 
for this visit. 
 
 

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2.19 Study Assessments 
The schedule of assessments is shown in Table 2 below. 
Table 2 Schedule of Assessments 
1Basic metabolic profile 
2Required for patients who are sexually active 4 weeks prior to the questionnaire completion date 
3Only urological SAEs and urological adverse event related medication and all BPH medication 
4Only urological SAEs and urological adverse events 
 
Medical history: During the baseline assessment, the investigator or coordinator will record details 
of medical history as they relate to BPH. 
Serum Blood Test: A blood sample should be collected prior to the surgical procedure to measure 
PSA, complete blood count (CBC), and Basic Metabolic Panel (BMP) to include at least levels of 
creatinine, sodium, and blood urea nitrogen. A CBC and BMP should also be collected following 
the first voiding trial and prior to discharge. PSA will also be repeated at 6 months, 12 months, 24 
months, 36 months, 48 months, and 60 months follow-up visit. 
Uroflowmetry: Uroflowmetry test is performed at baseline, 1 month, 3 months, 6 months, 12 
months, 24 months, 36 months, 48 months, and 60 months follow-up visit. For Qmax to be valid 
for a patient, the total voided volume must be ≥ 125mL.  If the total voided volume is less than 
125mL, the voided volume must be equal to or greater than 50% of the bladder capacity (defined 
as voided volume + PVR).  The patient can repeat the test if necessary. 
 
Evaluation 
Baseline 
w/in 90 
days of 
Tx 
Treat
ment 
Discharge 
1 
Month 
(+/-5 
days) 
3 
Months 
(+/-10 
days) 
6 
Months 
(+/-30 
days) 
12 
Months 
(+/-60 
days) 
24,36, 
48, 60 
Months 
(+/-60 
days) 
Medical History + 
Demographics 
X 
 
 
 
 
 
 
 
Serum Blood Test – 
CBC & BMP1 
X 
 
X 
 
 
 
 
 
PSA 
X 
 
 
 
 
X 
X 
X 
Uroflow + PVR 
X 
 
 
X 
X 
X 
X 
X 
Incontinence Severity 
Index 
X 
 
 
X 
X 
X 
X 
 
IPSS 
X 
 
 
X 
X 
X 
X 
X 
Pain Intensity Scale 
(NRS) & Dysuria 
Questionnaires 
X 
 
 
X 
X 
X 
 
 
Sexual Function (IIEF-
15, MSHQ-EjD)2 
X 
 
 
X 
X 
X 
X 
 
Quality of Recovery 
 
 
X 
X 
X 
X 
X 
 
TRUS 
X 
X 
 
 
X 
 
 
 
Concomitant 
Medication 
X 
X 
X 
X 
X 
X 
X 
X3 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X4 

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Incontinence Severity Index:  ISI1 is a validated means of assessing incontinence and will assist 
in isolating de novo incontinence rather than pre-existing incontinence secondary to Bladder Outlet 
Obstruction (BOO). This questionnaire will be completed at baseline, 1 month, 3 months, 6 months 
and 12 months follow-up visit. 
International Prostate Symptom Score (IPSS):  IPSS2 is a validated measure of urinary 
dysfunction due to BPH.  This questionnaire will be completed at baseline, 1 month, 3 months, 6 
months, 12 months, 24 months, 36 months, 48 months, and 60 months visit. 
Pain Severity Assessment (NRS) and Dysuria Score: NRS and Dysuria Scores are a method of 
measuring post-operative pain and pain on micturition. This questionnaire will be completed at 
baseline, 1 month, 3 months and 6 months follow-up visit.  
International Index of Erectile Function Questionnaire (IIEF-15): IIEF-153 is a validated, 
fifteen-item questionnaire designed to diagnose the presence and severity of erectile dysfunction. 
This questionnaire will be completed at baseline, 1 month, 3 months, 6 months, and 12 months 
follow-up visit. IIEF-5 is a subset of IIEF-15 that has also been validated for the measurement of 
erectile function.4 
Male Sexual Health Questionnaire to assess Ejaculatory Dysfunction (MSHQ-EjD):  MSHQ-
EjD5 is a validated, four-item questionnaire that assesses ejaculatory function and related distress 
or bother. This questionnaire will be completed at baseline, 1 month, 3 months, 6 months, and 12 
months follow-up visit. 
Quality of Recovery. This is a validated visual analog scale rating of quality of recovery from 
surgery6. The scale extends from “poor recovery” to “excellent recovery.” 
Transrectal ultrasound (TRUS):  TRUS will be performed to assess eligibility for prostate 
volume, length, transverse width, anterior/posterior width, and general condition of the prostate. 
Presence of a middle or intravesical lobe should be documented by sagittal images. TRUS will be 
conducted at baseline, treatment, and 3 months follow-up visit.  
Concomitant Medications: The following will be recorded on a rolling log: BPH medication, post-
operative pain medication, all AE related medications up to the 12 months visit, and all urological 
SAE and urological AE related medications for the 24 months, 36 months, 48 months, and 60 
months visits. 
2.20 Adverse events 
The occurrence of all adverse events will be documented in all study subjects throughout the study 
treatment and 12 months follow-up period. Only urological SAEs and urological events will be 
collected at 24 months, 36 months, 48 months, and 60 months follow-up visits. AE information 
(start and stop date, description of event, severity, relatedness to the treatment procedure, the device 
itself or other study-related procedures) will be assessed and recorded on CRFs. Whether an AE 
meets the definition for serious adverse event will be determined by the study investigator using 
Table 3. All urological events consistent with a SAE must be reported to the Sponsor within 24 
hours of awareness of the event. Relatedness of the AE to the surgical procedure or the study device 
itself will be judged by the clinical events committee (CEC) for adverse events up to 12 months 
according to Table 4. 

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The classification of surgical complications shall be done per Table 5 by the CEC. Note that 
persistent ejaculatory or erectile dysfunction, the need for re-catheterization after postoperative day 
3, and urinary incontinence related to surgery are considered to be surgical complications. 
 
Table 3 Adverse Event Definitions 
Term 
Definition 
Adverse event* (AE) 
Any untoward medical occurrence in a subject. 
Serious adverse event* 
(SAE) 
An adverse event that: 
• 
led to a death, 
• 
led to a serious deterioration in the health of the subject that 
• 
resulted in a life-threatening illness or injury, 
• 
resulted in a permanent impairment of a body structure 
or a body function, 
• 
required hospitalization or prolongation of existing 
hospitalization, 
• 
resulted in medical or surgical intervention to prevent 
permanent impairment to body structure or function, 
• 
led to fetal distress, fetal death, a congenital 
abnormality, or birth defect. 
Adverse device effect 
(ADE) 
Any untoward and unintended response to a medical device. 
This term includes any event resulting from insufficiencies or 
inadequacies in the instructions for use or the deployment of the 
device or any event resulting from user error. 
Serious adverse device 
effect (SADE) 
An adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event or that 
might have led to any of these consequences if suitable action had 
not been taken or intervention had not been made or if 
circumstances had been less opportune. 
Unanticipated Adverse 
Device Effect (UADE) 
Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a 
device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary 
plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or 
welfare of subjects. 
*Note that these definitions do not imply a relationship between the adverse event and the AQUABEAM System. 
Non-Reportable Events - Mild to moderate symptoms that are typically associated with the usual 
post-operative course including but not limited to dysuria, decreased urinary flow, gross hematuria 
within 7 days post treatment. 
Ejaculatory dysfunction – The absence of seminal emission 
Erectile dysfunction – The inability to achieve and maintain an erection sufficient for satisfactory 
sexual activity 
Urinary Retention – Subjects with an episode of the inability to urinate without the use of a 
catheter  
Urinary Retention Adverse Event – Subjects who present beyond 7 days post-index treatment 
and are unable to void requiring catheterization to resolve their symptoms  

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Urinary Incontinence – Subjects who didn’t require incontinence pads prior to Aquablation 
treatment and require 1 or more incontinence pads per day post-index treatment. 
 
Table 4 Adverse event relatedness categories 
Term 
Definition 
Unrelated 
No evidence that AE related to Aquablation procedure or AQUABEAM System 
Unlikely 
AE has a low likelihood of being related to Aquablation procedure or AQUABEAM System 
Possible 
AE could be related to Aquablation procedure or AQUABEAM System but an alternative 
explanation is also likely 
Probably 
AE likely to be related Aquablation procedure or AQUABEAM System even though 
alternative explanations are possible 
Definitely 
AE almost certainly related to Aquablation procedure or AQUABEAM System 
 
Table 5 Clavien-Dindo grading system7 
Grade 
Definition 
Grade 1 
Any deviation from the normal postoperative course without the need for 
pharmacological treatment or surgical, endoscopic and radiological interventions 
Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, 
diuretics and electrolytes and physiotherapy. This grade also includes wound infections 
opened at the bedside.† 
Grade 2 
Requiring pharmacological treatment with drugs other than such allowed for grade I 
complications. Blood transfusions and total parenteral nutrition are also included.* 
Grade 3 
Requiring surgical, endoscopic or radiological intervention. 
Grade 3a 
Intervention not under general anesthesia. 
Grade 3b 
Intervention under general anesthesia. 
Grade 4 
Life-threatening complication (including CNS complications: brain haemorrhage, 
ischaemic stroke, subarachnoid bleeding, but excluding transient ischaemic attacks) 
requiring IC/ICU management. 
Grade 4a 
Single organ dysfunction (including dialysis). 
Grade 4b 
Multi-organ dysfunction. 
Grade 5 
Death of a subject. 
*Note that the need for medications related to BPH (e.g., alpha blockers) is likely related to lack of effectiveness (not 
safety) and is not considered to meet criteria for a Grade 2 event. 
 
†This includes the following: persistent ejaculatory dysfunction, erectile dysfunction or urinary incontinence and 
urinary retention requiring re- catheterization after 3 days post-procedure. Note that bladder catheterization itself is 
considered a Clavien-Dindo Grade 1 event 
 
2.21 Study Withdrawal  
Subjects may be terminated or withdrawn from the study for the following reasons: 
• 
Voluntary withdrawal: the subject voluntarily chooses not to further participate in the study. 
• 
Subject death. 

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• 
At the discretion of the Principal Investigator, or where the ongoing participation of the patient 
involves a risk greater than perceived benefit. 
• 
The Sponsor may terminate the study at any time. 
2.22 Lost to Follow-Up 
A subject will be considered “lost to follow up” and terminated from the study when he can no 
longer be reached by study staff and has missed two consecutive follow up visits.  Documentation 
of the unsuccessful attempts by the Investigator or his/her designee to contact the subject or next 
of kin need to be filed with the study exit form. 
2.23 Study Termination 
The sponsor has the right to discontinue the study at any time for any reason. 
2.24 Case Report Forms (CRF) 
Data will be entered into an EDC system.  If a consented subject is not treated, a study exit form 
will be completed to record the reason for screen fail or withdrawal. 
2.25 Study Exit 
The subject’s participation in the study is considered complete at the end of the 60 months visit or 
if the subject withdraws from the study or loss to follow-up. A study exit form shall be completed. 
3 STUDY ENDPOINTS 
3.1 Primary Efficacy Endpoint 
The primary efficacy endpoint is the change in total IPSS score at 3 months as compared to baseline. 
3.2 Primary Safety Endpoint 
The primary safety endpoint is the proportion of subjects with adverse events rated as probably or 
definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 
1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced 
through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading 
postoperative complications not events that reflect lack of effective treatment. 
3.3 Secondary Endpoints for Marketing Claims 
Secondary endpoints are: 
• 
Length of procedure time as defined as AQUABEAM Handpiece insertion to insertion of 
indwelling catheter. Mean and 95% confidence intervals will be calculated. There is no 
statistical hypothesis for this endpoint; it is considered informational. 
• 
Proportion of subjects, who were sexually active at baseline and experienced either ejaculatory 
or erectile dysfunction (per protocol definitions) at 3 months. An exact binomial confidence 
interval will be calculated; there is no statistical hypothesis. 
• 
Change from baseline to 3 months in Qmax.  For a patient with a urinary catheter in place at 
the time testing, the Qmax value will be zero. Mean and confidence intervals will be calculated 
and a historical semi-quantitative comparison will be made with WATER Study data or other 
studies. 

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• 
Change from baseline to 3 months in PVR.  For a patient with a urinary catheter in place at the 
time testing, the PVR value will be Not Applicable. Mean and confidence intervals will be 
calculated and a similar semi-quantitative comparison will be made. 
• 
Change from baseline to 6 months in PSA. Mean and confidence intervals will be calculated. 
A t test will be used to compare PSA change vs. a null hypothesis of no change. 
• 
Mean change from baseline in MSHQ-EjD score at 3 months. Preservation of ejaculatory 
function, meaning a change non-inferior to -4 points. A t test with 95% confidence intervals 
will be used to evaluate this hypothesis.  
• 
Mean change from baseline in IIEF-5 (aka SHIM, part of IIEF-15) at 3 months. Preservation 
of erectile function, meaning a change score non-inferior to -6 points. An approach similar to 
that listed for MSHQ-EjD will be used. 
• 
Re-intervention rate at 3 months.  Re-intervention is defined as the need for additional tissue 
resection following the index procedure. An exact binomial confidence interval will be 
calculated. No statistical hypothesis is proposed. 
• 
Subjects who entered the trial using a urinary catheter at any time 45 days prior to enrollment 
will yield more than 50% not needing a catheter at any time 45 days prior to the 3 months visit. 
An exact binomial confidence interval will be calculated. No statistical hypothesis is proposed. 
3.4 Additional Endpoints 
Additional analysis of data collected may be performed and reported. 
4 STATISTICAL ANALYSIS 
4.1 General Approach 
Continuous Outcomes. Continuous outcomes will be summarized with mean, standard deviation 
and other relevant statistically summaries. When not normally distributed, medians and quantiles 
will be reported. A confidence interval approach may be used, if appropriate, to compare outcomes 
with historical information. Repeated measures analysis of variance may be used for outcomes 
assessed multiple times over the course of follow-up. 
Binary Outcomes. Binary and ordinal outcomes will be tabulated. Rates will be expressed as a 
percentage taking into account denominators as listed above. If required, confidence intervals for 
proportions will be calculated using the exact binomial distribution. A confidence interval approach 
may be used to compare outcomes with historical information. Comparisons of proportions will be 
done with chi-squared or Fisher’s exact test. Multivariate analysis may also be performed. 
4.2 Primary Endpoint Calculation and Sample Size Determination 
Prior studies have shown that IPSS scores are reduced by approximately 16 points after 
Aquablation,8,9 values similar to those observed after TURP.10 In patients with moderate-to-severe 
BPH, the mean change in IPSS score representing slight improvement is approximately 5 points.11  
Therefore, showing a mean reduction in IPSS scores that statistically exceeds 16-5 = 11 points will 
be interpreted as study success. The study’s primary endpoint hypothesis is a one-way statistical 
test (alpha=.025 for interpretation): 
H0: Mean(IPSS change score at 3 months) ≤ 11 
Ha: Mean(IPSS change score at 3 months) > 11 

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With 100 patients and assuming 10% subjects lost to follow, 90 evaluable subjects with an 
underlying change of 16 points and a change score SD of 7.5 points yields a 99% power to detect 
an improvement of more than 11 points. 
The WATER study (IDE#G150089) used an assumption that a TURP rate for the same safety 
definition provided in this protocol would by 65% for a range of prostate sizes 30-80mL.  The same 
safety target will be used for this protocol treating large prostates of 80-150mL.  The assumed true 
rate for the Aquablation patients will be 50% (10% greater than WATER in order to account for 
treating larger prostates).  The study’s primary endpoint hypothesis is a one-way statistical test 
(alpha=.025 for interpretation): 
H0: Mean (safety rate at 3 months) ≥ 65% 
Ha: Mean (safety rate at 3 months) < 65% 
The primary safety endpoint with 90 evaluable subjects has an 80% power to detect a safety rate of 
less than 65%. 
5 RISK/BENEFIT ANALYSIS 
The study protocol has been designed to provide the greatest benefits while assuring the safety of 
participating subjects by mitigating the occurrence, limiting the severity, and ameliorating the 
effects of any possible adverse events. The following describes the benefits subjects will receive as 
well as possible adverse events which have been identified as risks and for which subjects will be 
carefully monitored. 
5.1 Potential Benefits 
The primary potential benefit of participation is the potential occurrence of successful treatment of 
lower urinary tract symptoms using the AQUABEAM System. Additional benefits may be decreased 
post-operative duration of pain, decreased need for urinary catheter postoperatively, and faster 
overall recovery. In a patient with urinary retention, the need for catheter use (indwelling or 
intermittent) may be reduced. 
5.2 Potential Risks 
The AQUABEAM System is used during a surgical procedure on the lower urinary tract. Risks 
associated with surgical procedures, some of which could be fatal, include: 
• 
Irritative symptoms of urgency, hesitancy, dysuria, and nocturia 
• 
Bleeding 
• 
Lower urinary tract infection 
• 
Bladder, rectum, or prostate injury 
• 
Reaction to anesthesia 
• 
Sphincter damage 
• 
Urinary extravasation 
• 
Swelling or irritation of the prostate, bladder, perineum, or urethra 
• 
Pain 
• 
Changes in ejaculatory function 
• 
Reproductive system disturbances 
• 
Blood Transfusion 
• 
Perforation 

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5.3 Risk Mitigation 
Risks during study participation will be minimized by the following: 
• 
The study protocol was developed in concert with the study’s principal investigator, who is 
well-known in the area of BPH treatment 
• 
The site was chosen because of proven expertise in the field of urological surgery 
• 
The investigator will receive specific training and instruction in the use of the AQUABEAM 
System 
• 
Study subjects undergo intensive monitoring throughout the study by a multidisciplinary team 
• 
Pre-clinical, in vitro, and in vivo testing has been performed in order to optimize the device 
safety and function 
• 
Clinical testing in previous human subjects has been performed in order to optimize the device 
safety and function 
6 STUDY ADMINISTRATION  
6.1 Clinical Events Committee 
An independent Clinical Events Committee (CEC), consisting of three physicians who are not study 
Investigators will be utilized for this trial. This CEC will be responsible for the review and 
adjudication of reported adverse events up to 12 months related to the device or the procedure that 
occur over the course of the study per the CEC Charter. Additionally, the CEC may adjudicate 
other events at the request of the Data Monitoring Committee or Sponsor. The CEC adjudicators 
shall classify (assign relatedness) the above described adverse events based on severity and 
association to the procedure or other attribution. 
Device- or procedure-related events which are associated with the secondary safety endpoint 
analysis will be as adjudicated by the CEC. In the event the CEC differs from the Investigator in 
classification of events, the resulting CEC adjudication will be used for final analysis and reporting. 
A CEC Charter will be developed prior to the start of study enrollment. The CEC Charter shall 
include consistent definitions for each type of event and shall outline the review process. 
6.2 Data Monitoring Committee 
The Data Monitoring Committee (DMC) will consist of a minimum of three (3) members and this 
group shall also act as the steering committee chartered with advising the sponsor on the design 
and execution of the study, monitoring the overall implementation of the study, including subject 
enrollment, protocol compliance, and reviewing the final primary endpoint analysis (3 months 
follow-up). 
Membership will include only independent members and therefore will not include a study 
investigator or a representative from the sponsor. The DMC meetings will consist of open and 
closed sessions (i.e. “open” denotes sponsor staff present; “closed” denotes without sponsor staff 
present).  
The sponsor or designate will provide the DMC with reports related to subject enrollment, 
procedural outcome, follow-up visits, adverse events, and any other material the DMC may deem 
necessary to carry out its responsibilities as established at the outset of the committee in the DMC 
charter. The DMC will assess if early evidence exists for dramatic benefit or harm for subjects 
while the clinical study is in progress. The DMC will make recommendations to the sponsor 
concerning continuation, modification, or termination of the study.  

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The DMC will establish and maintain a Charter detailing specific operating procedures.  Names 
and contact information for all DMC members will be on-file at the sponsor and available on 
request. 
6.3 Data Collection/Electronic Case Report Forms (e-CRF) 
Case report forms will be used to collect all subject data during the study within the EDC system 
and are referred to as eCRFs.  The EDC system enables rapid data acquisition and cleaning through 
extensive data checking and query processing.  Monitor visits will be conducted in regular intervals 
through the study based upon site enrollment rates. 
Data will be entered into a secure EDC system, which allows 21 CFR Part 11 compliance. Subjects’ 
follow up visits data will be entered directly by the site with corresponding source documents 
maintained at the site level. 
6.4 Clinical Monitoring 
The study will be monitored to ensure that applicable regulations are followed. Written procedures 
will be established by PROCEPT BioRobotics or their authorized designee to ensure the quality of 
the study and to ensure that each person involved in the monitoring process carries out the required 
duties. 
Prior to subject enrollment, a study initiation visit will be completed at each investigational site to 
ensure the following: 
• 
IRB approval has been obtained and documented 
• 
The Investigators and study personnel are appropriately trained and clearly understand the 
study 
• 
The Investigators and study personnel accept the obligations incurred in undertaking this 
clinical investigation. 
Periodic monitoring visits will be made at all active study sites throughout the clinical study to 
assure that the Investigator obligations are fulfilled and all applicable regulations and guidelines 
are followed. These visits will assure that the facilities are still acceptable, the protocol and 
investigational plan are being followed, the IRB has been notified of approved protocol changes as 
required, complete records are being maintained, appropriate and timely reports have been made to 
the Sponsor and the IRB, device and device inventory are controlled, and the Investigator is 
carrying out all agreed activities. 
A study termination visit will be conducted at the completion of the clinical investigation to ensure 
that all subject data are properly documented and that all clinical materials are returned to 
PROCEPT BioRobotics.   
If a clinical monitor becomes aware that an Investigator is not complying with the signed 
Investigator’s Agreement, the Investigational Plan, the requirements of Investigational Device 
Exemption regulations (21 CFR 812), or any conditions of approval imposed by the IRB, 
PROCEPT BioRobotics will either secure compliance or discontinue shipments of the device to 
the Investigator and terminate the Investigator’s participation in the investigation. 
 

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7 STUDY REPORT AND PUBLICATION STRATEGY 
7.1 Final Study Report 
A Final Study Report will be prepared by PROCEPT BioRobotics. 
7.2 Publication Strategy 
The study will be registered with a clinical trials database, as recommended by the International 
Committee of Medical Journal Editors. 
The Principal Investigator agrees to provide copies of any and all proposed manuscripts to 
PROCEPT BioRobotics at least 30 days in advance of submitting such proposed manuscripts to a 
publisher or other third party to evaluate the proposed manuscript for the following purposes: 
• 
For accuracy and consonance with the study database, 
• 
To ascertain whether confidential information or other proprietary information of PROCEPT 
BioRobotics (including trade secrets and patent protected materials) is being inappropriately 
utilized and/or released, 
• 
To provide Principal Investigator with information which may not yet be available to them, 
and 
• 
To provide input from other Investigators and Co-Investigators in the study, if any, regarding 
the content and conclusions of the proposed manuscripts. 
For the avoidance of doubt, PROCEPT BioRobotics may not require any amendments to be made 
to the clinical data, omissions to be made to it or amendments to the Principal Investigator’s 
interpretation thereof. The decision as to whether to amend the manuscript to include any or all of 
the opinions or information provided by PROCEPT BioRobotics remains that of the Principal 
Investigator. 
If PROCEPT BioRobotics makes a good faith determination, within such 30-day period, that the 
publication or presentation would be detrimental to its intellectual property interests, the Principal 
Investigator shall refrain from submitting such proposed manuscript to a publisher or other third 
party for another 365 days or such earlier time that notifies PROCEPT BioRobotics to allow time 
to file PROCEPT BioRobotics patent applications or take other steps to protect its intellectual 
property interests. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Hanley, J., Capewell, A. & Hagen, S. Validity study of the severity index, a simple measure 
of urinary incontinence in women. BMJ 322, 1096–1097 (2001). 
2. Barry, M. J. et al. The American Urological Association symptom index for benign prostatic 
hyperplasia. The Measurement Committee of the American Urological Association. J. Urol. 
148, 1549–1557; discussion 1564 (1992). 
3. Rosen, R. C. et al. The international index of erectile function (IIEF): a multidimensional 
scale for assessment of erectile dysfunction. Urology 49, 822–830 (1997). 
4. Rosen, R. C., Cappelleri, J. C., Smith, M. D., Lipsky, J. & Peña, B. M. Development and 
evaluation of an abridged, 5-item version of the International Index of Erectile Function 
(IIEF-5) as a diagnostic tool for erectile dysfunction. Int. J. Impot. Res. 11, 319–326 (1999). 
5. Rosen, R. C. et al. Development and validation of four-item version of Male Sexual Health 
Questionnaire to assess ejaculatory dysfunction. Urology 69, 805–809 (2007). 
6. Myles, P. S. et al. Development and psychometric testing of a quality of recovery score after 
general anesthesia and surgery in adults. Anesth. Analg. 88, 83–90 (1999). 
7. Dindo, D., Demartines, N. & Clavien, P.-A. Classification of surgical complications: a new 
proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann. Surg. 240, 
205–213 (2004). 
8. Gilling, P., Reuther, R., Kahokehr, A. & Fraundorfer, M. Aquablation - image-guided robot-
assisted waterjet ablation of the prostate: initial clinical experience. BJU Int. 117, 923–929 
(2016). 
9. Gilling, P., Tan, A. & Anderson, P. Aquablation of the Prostate for Symptomatic Benign 
Prostatic Hyperplasia: One-Year Results. J Urol (2017). 
10. Marszalek, M., Ponholzer, A., Pusman, M., Berger, I. & Madersbacher, S. Transurethral 
Resection of the Prostate. Eur. Urol. Suppl. 8, 504–512 (2009). 
11. Barry, M. J. et al. Benign prostatic hyperplasia specific health status measures in clinical 
research: how much change in the American Urological Association symptom index and the 
benign prostatic hyperplasia impact index is perceptible to patients? J. Urol. 154, 1770–1774 
(1995).