Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies
Phase: NA
Conditions: Renal Transplant Donor of Left Kidney, Donor Nephrectomy, Robotic Surgery, Single-port
Sponsor: University of Maryland, Baltimore

NCT 01925677 
 
Use of the Intuitive Surgical da Vinci® Single-Site™ with 
Instruments and Accessories for Single-Port Laparoscopic 
Nephrectomies 
 
March 5, 2013 
 
 
 
 

Protocol synopsis  
 
Title of study: A six month, single-center, feasibility study of the use of the Intuitive 
Surgical da Vinci® Single-Site™ Instruments and Accessories for Single-Port 
Laparoscopic Nephrectomies 
Purpose and rationale: After being informed of the potential risks and off-label use of 
the da Vinci Single-Site approach in our study, patients will undergo a robotic-assisted 
single-site donor nephrectomy performed by a two-surgeon team utilizing existing da 
Vinci instrumentation and Single-Site platforms. Renal mobilization and vascular 
dissection will be performed with manual laparoscopy performed for vascular division 
utilizing stapling devices.  
 
Objectives: The primary objective is to measure the feasibility of the current Single-Site 
platform to perform donor nephrectomy prior to vascular division and kidney extraction. 
 
Population: The proposed study population consists of adults aged between18-70 who 
have been previously approved by the living donor transplant committee at the University 
of Maryland Medical Center as appropriate candidates for renal donation. 
 
Inclusion criteria: The following criteria must be met in order for a patient to participate 
in the study. Male or female adults ages from 18 to 70 who are good general health, and 
who have a genuine altruistic motivation. The patient must also have compatible blood 
type with the recipient, a body mass index less than 35, and appropriate for left kidney 
donation. Approval by the Living Donor Center must also be met in order to participate 
in the trial. 
 
Exclusion criteria: The following criteria will exclude any patients from participating in 
the clinical trial. Any patients suffering from cancer, diabetes, kidney disease, heart 
disease, liver disease, sickle cell disease, HIV or hepatitis, previous major abdominal 
surgery, or more than two left renal arteries. 
 
Study design: After obtaining informed consent patients will be screened for eligibility. 
Patients will undergo a robotic-assisted single-incision laparoscopic donor nephrectomy 
with the use of the da Vinci Surgical System with the Single-Site platform.  
Figure 1-1 Study Design 

 
 
Efficacy assessments: Measurement of the ability of the current Single-Site platform to 
assist laparoscopic donor nephrectomy procedure prior to final extraction of the donor 
kidney. 

Data analysis: Statistical analysis will be performed on ergonomic and other collected 
data during the operative procedures and compared to matched patients. The proposed 
study of 20 patients may not generate statistically significant conclusions; however, we 
believe our observations will provide valid conclusions that support the use and 
continued development of robotic single port donor nephrectomy. 
Sample size justification: The sample size was determined to provide a pilot group that 
could potentially demonstrate the efficacy of the da Vinci Surgical System with the 
Single-Site platform in donor nephrectomies. 
 
1.0 Background  
Minimally invasive surgery has been an important factor responsible for the 
expansion of living renal donation since its advent over a decade ago. Presently, more 
than 6000 laparoscopic donor nephrectomies are performed annually in the United States. 
While the number of living kidney donors has plateaued over the last decade, the number 
of recipients awaiting transplantation has more than doubled to nearly 90,000. 
Refinements in minimally invasive surgical approaches may encourage additional 
suitable individuals to consider kidney donation.  
 
Laparoendoscopic single site (LESS) surgery was introduced as one technique to 
further decrease the invasiveness of laparoscopic surgical approaches. We initiated our 
single-port donor nephrectomy program in 2009 and have reported the World’s largest 
series. This series clearly supports the safety and improved outcomes associated with this 
approach. New instrumentation may further decrease the learning curve and operative 
times associated with single-port techniques. The robotic single-port platform has 
demonstrated feasibility in a variety of procedures.  
 
Our center has performed over 200 single-port donor nephrectomies with standard 
laparoscopy and has reported patient benefits associated with a single port approach1. The 
single port robotic platform offers the potential to ameliorate the significant technical and 
ergonomic challenges that currently limit more widespread application of single port 
donor surgery. 
2.0 Purpose and rationale  
After being informed of the potential risks and off-label use of the da Vinci Single-Site 
approach in our study, patients will undergo a robotic-assisted single-site donor 
nephrectomy performed by a two-surgeon team utilizing existing da Vinci 
instrumentation and Single-Site platforms. Renal mobilization and vascular dissection 
will be performed with manual laparoscopy performed for vascular division utilizing 
stapling devices. 
 
3.0 Objectives  
3.1 Primary objective  

The primary objective is to measure the feasibility of the current Single-Site platform to 
perform donor nephrectomy prior to vascular division and kidney extraction. 
3.2 Secondary objectives  
Secondary objectives include operative times, blood loss, and surgeon ergonomics as 
measured via techniques developed in our surgical simulation center. 
 
4.0 Study design  
Hypothesis:  We believe that the da Vinci system and its single port platform will offer 
solutions to the challenges of visualization, instrument articulation, and ergonomics that 
limit the widespread application of single-port donor nephrectomy as the preferred 
approach for renal donation. 
Methods: We will perform an IRB-approved study of the use of the da Vinci Surgical 
System with Single-Site technology in donor nephrectomies. The IRB proposal and 
consent will be constructed to provide kidney donors with the opportunity to participate 
in our study. Patients will be informed of the potential risks and off-label use of the da 
Vinci Single-Site approach in our study. Because the standardized approach for renal 
donation at our center is single port donor nephrectomy, we anticipate enrollment of up to 
20 patients for this study. 
Patients will undergo robotic-assisted single-site nephrectomy performed by a two-
surgeon team utilizing existing da Vinci instrumentation and Single Site platforms. Renal 
mobilization and vascular dissection will be performed with conversion to standardized 
laparoscopy for the final stages of vascular division with stapling devices and extraction. 
The primary objective is a feasibility measure of the ability of the current Single-Site 
platform to perform major portions of the procedure. Secondary objectives include 
operative times, blood loss, and surgeon ergonomics as measured via techniques 
developed in our surgical simulation center. Study cases will be compared to existing 
matched cohorts of single port donor nephrectomy cases performed by manual 
laparoscopy. The study population will include adults aged 18 to 70 of both genders who 
meet our center’s criteria for renal donation and who consent to participate in the study. 
Our sample size of 20 patients is proposed to initiate this pilot study of the feasibility of 
robotic single port donor nephrectomy. 
Statistical analysis will be performed on ergonomic and other collected data during the 
operative procedures and compared to matched patients. The proposed study of 20 
patients may not generate statistically significant conclusions; however, we believe our 
observations will provide valid conclusions that support the use and continued 
development of robotic single port donor nephrectomy techniques. 
Table 1 Study Design 

 
5.0 Population  
The proposed study population consists of adults aged between18-70 who have been 
previously approved by the living donor transplant committee at the University of 
Maryland Medical Center as appropriate candidates for renal donation. 
 
5.1 Inclusion criteria  

The following criteria must be met in order for a patient to participate in the study. Male 
or female adults ages from 18 to 70 who are good general health, and who have a genuine 
altruistic motivation. The patient must also have compatible blood type with the recipient, 
a body mass index less than 35, and appropriate for left kidney donation. Approval by the 
Living Donor Center must also be met in order to participate in the trial. 
 
5.2 Exclusion criteria  
The following criteria will exclude any patients from participating in the clinical trial. 
Any patients suffering from cancer, diabetes, kidney disease, heart disease, liver disease, 
sickle cell disease, HIV or hepatitis, previous major abdominal surgery, or more than two 
left renal arteries. 
 
6.0 Treatments  
The study is a feasibility study. Patients will undergo a donor nephrectomy with the 
assistance of the investigational device, the da Vinci Surgical System with the Single-Site 
Instruments and Accessories.  
6.1 Investigational device 
The investigational device, the da Vinci Surgical System with the Single-Site Instruments 
and Accessories will be used to perform major portions of the procedure prior to vascular 
division and extraction.  
6.2 Treatment arms  
During pre-admission testing, if the patient has met all inclusion/exclusion criteria, 
patients will be enrolled into the treatment group.  
6.3 Treatment assignment  
Once a potential study patient is identified and he/she fulfills the inclusion/exclusion 
criteria and the informed consent form is signed, the patient will be entered into the 
study. The patient will be assigned a patient identification number (see Section 6.5.1).  
6.4 Treatment blinding  
Not applicable 
 
6.5 Treating the patient  
6.5.1 Patient numbering  
Each patient is uniquely identified in the study by a patient number. The first patient is 
assigned patient number 1, and subsequent patients are assigned consecutive numbers 
(e.g. the second patient is assigned patient number 2, the third patient is assigned patient 
number 3). Once assigned to a patient, a patient number will not be reused. If the patient 
fails to be enrolled for any reason, the reason for not being enrolled will be entered on the 
Screen Failure eCRF.  
6.5.2 Use of the study device  

The study site will be supplied with an investigational device by Intuitive Surgical 
Systems and it will be used by three qualified surgeons. 
6.5.3 Study device supply, storage and tracking  
The study device will be received by a designated person at the study site, handled and 
stored safely and properly, and kept in a secured location to which only the investigator 
and designated assistants have access. Upon receipt, all study devices will be stored 
according to the instructions specified on the device labels. Clinical supplies will be 
dispensed only in accordance with the protocol. Device labels will be in the local 
language and comply with all legal requirements. The investigator will maintain an 
accurate record of the shipment and dispensing of study device in a device accountability 
ledger. Monitoring of device accountability will be performed by the field monitor during 
site visits and at the completion of the trial. All unused study devices, packaging, and 
device labels will be destroyed in conformance to University of Maryland Medical Center 
policies.  
 
6.5.4 Instructions using study device Not applicable.  
 
6.5.5 Permitted study device adjustments and interruptions Not applicable.  
 
6.5.6 Study device discontinuation and premature patient withdrawal Not applicable.  
 
6.5.7 Emergency unblinding of treatment assignment Not applicable.  
 
6.5.8 Study completion and post-study treatment  
At study completion CRF page should be completed after the operation.  Due to the 
nature of the study (a onetime exposure to the investigational device during the surgical 
procedure) withdrawal from the study cannot occur. Subjects who wish to withdraw from 
the study follow up will be permitted to do so.  
 
7.0 Visit schedule and assessments  
Table 7-1 lists all of the assessments and indicates with an “x” the visits when they are 
performed.  
 
 
 
 
 
 
 
 
 
Table 1 Assessment schedule 
 
 
Baseline 
Week 
 
 

Time Point 
0 
2 
4 
26 
Visit Number 
1 
3 
4 
5 
Informed Consent 
X 
 
 
 
Background Information 
X 
 
 
 
Inclusion/Exclusion 
X 
 
 
 
Med Hist/Demography 
X 
 
 
 
Vital Signs 
X 
X 
X 
X 
Physical Exam 
X 
X 
X 
X 
Laboratory Tests 
X 
X 
X 
X 
 
 
7.1 Information to be collected on screening failures  
Not Applicable 
 
7.2 Patient demographics/other baseline characteristics  
After informed consent has been signed and the patient’s eligibility to participate in the 
study has been determined, baseline patient information will be obtained, such as date of 
birth, age, sex, race, full relevant medical history/current medical conditions. 
A full physical examination will be made at baseline including vital signs, blood 
chemistry and hematology, serum creatinine, urinalysis, including a quantitative 
protein/creatinine ratio.  
7.3 Efficacy  
The observations to assess efficacy of the investigational device include the proportion of 
the surgical procedure able to be performed with the device, prior to standard 
laparoscopic techniques that will be employed in the final surgical steps. Efficacy will be 
specifically measured in operative time, blood loss, and successful completion of 
donation. Post-operative assessments will include patient satisfaction and recovery 
surveys. The efficacy variables selected are standard for this indication/patient 
population.  
7.4 Safety  
Safety assessments include blood loss, intraoperative complications or injuries to 
adjacent structures, and successful completion of donation surgery. These will be 

compared to center defined rates for these safety parameters. The safety assessments 
selected are standard for this indication/patient population.  
 
7.5 Other assessments  
7.5.1 Resource utilization  
For resource utilization, all relevant information about initial hospitalization and all 
follow-up hospitalizations post procdure (in the transplant study center or all other 
centers, if any) will be recorded.  The hospitalization data will include the main reason 
for admission and duration of hospitalization and length of stay. All attempts will be 
made to collect RU variables in all patients throughout the duration of the study in order 
to avoid selection bias. There may also be circumstances when the collection of such data 
after completion of the study may be warranted.  These data will be collected in the 
Hospitalization CRF and will be presented in a separate report.    
7.5.2 Health-related Quality of Life  
The SF-36 is a widely used instrument to measure generic health status.  It is a 36-item 
questionnaire that yields an 8-scale health profile as well as summary measures of 
individual patients. It has proven useful in monitoring generic and specific populations, 
comparing the relative burden of different diseases, differentiating the health benefits 
produced by different treatments, and in screening individual patients.  The purpose 
collecting SF-36 data in this study is to compare the final health status of those 
undergoing the robotic assisted single-incision laparoscopic donor nephrectomy.  
The eight profiles (scales) are: bodily pain, general health, vitality, mental health, 
physical functioning, role-physical, role-emotional and social functioning. The two 
summary measures are physical health and mental health.  
Patients will complete the questionnaire before other clinical assessments at any given 
visit. The SF-36 can be administered in 5 to 10 minutes with a high degree of 
respectability and quality. An appropriate person will be designated to facilitate self-
administration.  The administrator will not influence but will answer questions and 
address concerns to ensure that the questionnaire is filled out correctly and completely.  
Completed questionnaires will be reviewed and examined by the investigator before the 
clinical examination for responses which may indicate potential AEs or SAEs. The 
investigator will review not only the responses to the questions in the questionnaires, but 
he or she will also review for any unsolicited comments written by the patient. If the 
occurrence of AEs or SAEs is confirmed, the physician will record the events as per 
instructions given in Section 7.5.1 of the protocol. Investigators will not encourage the 
patients to change the responses reported.  
 
10 Data analysis  
10.1 Sets for analysis  
This study is not designed based on statistical power, thus statistical tests will not be 
performed as p-values would not be reliable and will lead to misinterpretation of the data. 

All analyses will be descriptive. 
10.2 Patient demographics/other baseline characteristics  
Demographic and other baseline characteristics will be presented by treatment group. 
Continuous variables will be summarized by sample size, mean, standard deviation, 
median, minimum and maximum.  
10.3 Analysis of the primary objective(s)  
 
10.3.1 Variable  
The primary objective is a feasibility assessment of the ability of the current Single-Site 
platform to perform major portions of the procedure prior to vascular division and 
extraction. This is a feasibility clinical study design to collect the primary evidence of 
safety and efficacy to support a marketing submission or application.  
 
10.4 Analysis of secondary objectives  
 
10.4.1 Efficacy (secondary)  
Secondary objectives include operative times, blood loss, and surgeon ergonomics as 
measured via techniques developed in our surgical simulation center. Study cases will be 
compared to existing matched cohorts of single port donor nephrectomy cases performed 
by manual laparoscopy.  
10.4.2 Safety 
Safety variables to be assessed include discontinuation from study, discontinuation from 
treatment, renal function, AE/infection, SAE, notable events, laboratory tests, and vital 
signs.  
Adverse events will be summarized by presenting, for each treatment group, the number 
and percentage of patients having any adverse event, having an adverse event in each 
organ system and having each individual adverse event. The same type of summaries will 
be provided for serious adverse events and for events suspected to be related to the study 
device. Any other information collected (e.g. severity or relatedness to study device) will 
be listed as appropriate.  
Laboratory data will be summarized by baseline values to most extreme post-baseline 
values, by presenting summary statistics of raw data and change from baseline values 
(means, medians, standard deviations, ranges) and by the flagging of notable values in 
data listings.  
Data from other tests (e.g. vital signs) will be listed, notable values will be flagged, and 
any other information collected will be listed as appropriate. Any statistical tests 
performed to explore the data will be used only to highlight any interesting comparisons 
that may warrant further consideration.  
The data collected will be presented in listings, summary tables and graphs.  
10.4.3 Resource utilization  

Data related to Resource Utilization will be used for the purpose of economic evaluation 
which will be analyzed in a separate report.  
10.4.4 Health-related Quality of Life  
The change from baseline in the profile and summary scores of the SF-36 will be 
assessed in the treatment group.  
 
10.5 Sample size calculation  
This study is a pilot study of 20 patients without additional sample size calculation.  
10.6 Power for analysis of critical secondary variables  
Not applicable.  
10.7 Interim analysis  
Routine follow-up appointments will occur 2 weeks and 6 months after operation.