Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study

Study Overview
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Brief Summary
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A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.

Detailed Description
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A prospective, multicenter investigation 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.

Official Title
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A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors

Conditions
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Oropharyngeal Cancer

Intervention / Treatment
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* Device: Transoral robotic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older T1 or T2 malignant oropharyngeal tumor Tumor amenable to transoral resection No previous treatment for the index tumor Willing and able to provide written informed consent Willing and able to comply with the study protocol requirements Exclusion Criteria: T3 or T4 stage tumor Previous radiation treatment to the head and neck, with or without chemotherapy Evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers Pre-operative expectation of needing microvascular soft-tissue reconstruction Tumor that invades and/or abuts the internal and/or external carotid artery Retropharyngeal carotid artery coincident with a tonsillar cancer or posterior pharyngeal wall cancer Evidence of mandibular invasion of tumor Eastern Cooperative Oncology Group Performance Status score greater than or equal to 2 On a medication that interferes with clotting that cannot be stopped prior to surgery Contraindication for general anesthesia or surgery Mentally handicapped or has psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent Pregnant or suspected to be pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transoral robotic surgery<br> | Device: Transoral robotic surgery<br>* Transoral robotic surgery for T1 & T2 oropharyngeal cancers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Performance defined as the conversion to an open approach required to complete the procedure | Intraoperative | 
| Number of Subjects With Device-related Serious Adverse Events | Safety is determined by measuring the number of subjects that experience device-related serious adverse events | Intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Surgical Margin | Rate of final positive surgical margins confirmed by pathology | Through14-days postoperatively |