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

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

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

Study Overview

• Status: Completed
• Conditions: Oropharyngeal Cancer
• Intervention / Treatment: Device: Transoral robotic surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Board of Trustees of the Leland Stanford Junior University
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Trustees of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transoral robotic surgery	Device: Transoral robotic surgery; Transoral robotic surgery for T1 & T2 oropharyngeal cancers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Christopher Holsinger, MD, Stanford University

Publications and helpful links

General Publications

• Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2017
• Primary Completion (ACTUAL): November 14, 2017
• Study Completion (ACTUAL): December 26, 2017

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (ACTUAL): February 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Oropharyngeal Neoplasms
• Other Study ID Numbers: ISI dV SP-TORS - 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes