A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors
Phase: NA
Conditions: Oropharyngeal Cancer
Sponsor: Intuitive Surgical

 
 
A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical 
System in TORS Procedures for Resection of Malignant Tumors 
Date: January 20, 2017 
IDE #: G160251  
NCT03049280 
 
 
SPONSOR: 
Intuitive Surgical, Inc. 
 
 
Notice:  All or part of the information contained in this document is the property of Intuitive 
Surgical, Inc. 

 
Property of Intuitive Surgical, Inc. 
 
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Study # 
dV SP-TORS -#01/ G160251 
Title 
A prospective, multicenter investigation of the da Vinci® SP™ Surgical 
System in Transoral Robotic Surgery (TORS) procedures for malignant 
tumors 
Study Design  
A prospective, multicenter, single-arm clinical investigation  
Study Enrollment 
and Follow-Up 
Enrollment is anticipated to take approximately 8 months and subjects 
will be followed for 7 weeks post-operatively 
Study Center(s) 
Three institutions in the United States – see Appendix II for study 
centers and participating investigators 
Number of Subjects 
The study will enroll a maximum of 33 subjects. This includes 30 
evaluable subjects and an assumed rate of 10% for subjects lost to 
follow-up. 
Study Objective 
To evaluate the safety and clinical performance of the da Vinci SP 
Surgical System, instruments, and accessories in TORS procedures for 
malignant oropharyngeal tumors classified as T1 and T2. 
Study Endpoints 
Primary Endpoints: 
 The primary performance endpoint is the conversion rate from da 
Vinci SP to an open approach required to complete the indicated 
procedure. 
 The primary safety endpoint is the incidence of device-related 
serious adverse events. 
 
Secondary Endpoint:   
 Rate of final positive surgical margins. 
Subject Study 
Assessments  
Pre-operative Assessment: Subject demographics, diagnostic tests to 
determine disease status and subject eligibility for TORS, pathology 
and dysphagia assessment by MD Anderson Dysphagia Inventory 
(MDADI) questionnaire  
Intra-Operative Assessments: Assessment of ability to complete 
surgical tasks and procedures (conversion to open approach), total 
operative time, robotic procedure time, estimated blood loss, incidence 
of blood transfusions, intra-operative adverse events, pathology report 
to assess surgical margins by immediate “frozen-section” technique 
Post-Operative (prior to discharge) Assessment: Length of hospital 
stay, CTCAE grading of hemorrhage, pathology to determine final 
surgical margins, adverse events, feeding tube dependency, return to 
oral diet, dysphagia assessment by MDADI questionnaire 
Post-Operative (14 ± 2 days) Assessment: Surgical margin status on 
final pathology report, adverse events, CTCAE grading of hemorrhage, 

 
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feeding tube dependency (if administered), return to oral diet, 
dysphagia assessment by MDADI questionnaire 
Post-Operative (7 weeks ±7 days) Assessment: Adverse events, 
CTCAE grading of hemorrhage, return to oral diet, feeding tube 
dependency, any re-hospitalization since discharge, dysphagia 
assessment by MDADI questionnaire 
Study Inclusion and 
Exclusion Criteria 
Inclusion Criteria: 
 Subject is 18 years or older  
 Subject clinically diagnosed with malignant oropharyngeal 
tumor classified as T1 or T2 
 Subject with an oropharyngeal tumor that is accessible and 
amenable to transoral resection 
 Subject without previous treatment for the index tumor 
(previous biopsy or excisional lymph node biopsy or neck 
dissection is allowed) 
 Subject is willing and able to provide written informed 
consent 
 Subject is willing and able to comply with the study 
protocol requirements 
 
Exclusion Criteria 
 Subject has been clinically diagnosed with T3 or T4 stage 
tumor 
 Subject has had previous radiation treatment to the head and 
neck, with or without chemotherapy 
 Subject with evidence of other primary cancers or distant 
metastasis or subject with synchronous primary tumor 
excluding skin cancers 
 Subject with pre-operative expectation of needing 
microvascular soft-tissue (“free-flap”) reconstruction 
 Subject with a tumor that invades and/or abuts the internal 
and/or external carotid artery 
 Subject with a retropharyngeal carotid artery coincident 
with a tonsillar cancer or posterior pharyngeal wall cancer 
 Subject with evidence of mandibular invasion of tumor  
 Subject with Eastern Cooperative Oncology Group (ECOG) 
Performance Status score greater than or equal to 2 
 Subject on a medication that interferes with clotting, 
including but not limited to Coumadin, Lovenox, or Plavix 
that cannot be stopped prior to surgery 
 Subject is contraindicated for general anesthesia or surgery 
 Subject is mentally handicapped or has a psychological 
disorder or severe systemic illness that would preclude 
compliance with study requirements or ability to provide 
informed consent 

 
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 Subject is pregnant or suspected to be pregnant 
Study Devices  
da Vinci  SP Surgical System & Instruments and Accessories 
Data Management 
Data management will be performed by Intuitive Surgical Inc. 
(Sponsor) or its appointed designee. 
Statistical 
Considerations & 
Data Analysis 
The recommended number of evaluable subjects in this confirmatory 
study (N=30) is not based on a formal sample size calculation.  It is 
intended to provide a measure by which the performance and safety of 
the da Vinci SP Surgical System in a clinical setting can be confirmed 
based on demonstrating equivalence with the da Vinci Si Surgical 
System via animal and cadaver testing. 
 
All evaluable subjects will be included for analysis regardless of the 
completeness of their data.  Analyses will be based on pre-operative 
characteristics, intra-operative and post-operative characteristics, and 
outcomes.  Standard univariate and bivariate techniques, where 
applicable, will be used to describe the clinical results of the study.  
Continuous variables will be described as a mean, standard deviation, 
and 95% confidence interval (i.e., total operative time, length of 
hospital stay, estimated blood loss).  Discrete variables will be 
described as a rate and a proportion of the total (i.e., conversions, 
complications). 
The data will be stratified by institution to understand the similarities 
and differences across patients and procedures.  A comparison of the 
results among institutions as well as the overall results will be 
described.  Where appropriate, the data will also be stratified by the 
representative procedures.  Methods appropriate for analyzing data 
where the outcome is time until the occurrence of an event, such as the 
case for resumption of swallowing function, return to oral diet, and 
feeding tube dependency, will be utilized. 
The results of this study will be compared to the results of the previous 
clinical study for TORS (K090993).  While formal statistical inference 
will not be made, the two studies will be compared on the basis of the 
95% confidence intervals for each outcome of interest.