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

Primary Purpose

Oropharyngeal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transoral robotic surgery
Sponsored by
Intuitive Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharyngeal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Board of Trustees of the Leland Stanford Junior University
  • Florida Hospital
  • Trustees of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transoral robotic surgery

Arm Description

Outcomes

Primary Outcome Measures

Performance
Performance defined as the conversion to an open approach required to complete the procedure
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

Secondary Outcome Measures

Positive Surgical Margin
Rate of final positive surgical margins confirmed by pathology

Full Information

First Posted
January 30, 2017
Last Updated
September 15, 2020
Sponsor
Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT03049280
Brief Title
Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
Official Title
A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
December 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transoral robotic surgery
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transoral robotic surgery
Intervention Description
Transoral robotic surgery for T1 & T2 oropharyngeal cancers
Primary Outcome Measure Information:
Title
Performance
Description
Performance defined as the conversion to an open approach required to complete the procedure
Time Frame
Intraoperative
Title
Number of Subjects With Device-related Serious Adverse Events
Description
Safety is determined by measuring the number of subjects that experience device-related serious adverse events
Time Frame
Intraoperative period
Secondary Outcome Measure Information:
Title
Positive Surgical Margin
Description
Rate of final positive surgical margins confirmed by pathology
Time Frame
Through14-days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Holsinger, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Board of Trustees of the Leland Stanford Junior University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Florida Hospital
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
Trustees of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31536129
Citation
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.
Results Reference
derived

Learn more about this trial

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

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