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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049280
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

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

Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Device: Transoral robotic surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : December 26, 2017

Arm Intervention/treatment
Experimental: Transoral robotic surgery Device: Transoral robotic surgery
Transoral robotic surgery for T1 & T2 oropharyngeal cancers




Primary Outcome Measures :
  1. Performance [ Time Frame: Intraoperative ]
    Performance defined as the conversion to an open approach required to complete the procedure

  2. Number of subjects with device-related serious adverse events [ Time Frame: Intraoperative through 7 weeks post-operative ]
    Safety is determined by measuring the number of subjects that experience device-related serious adverse events


Secondary Outcome Measures :
  1. Positive surgical margin [ Time Frame: Through14-days postoperatively ]
    Rate of final positive surgical margins confirmed by pathology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049280


Locations
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United States, California
Board of Trustees of the Leland Stanford Junior University
Palo Alto, California, United States, 94304
United States, Florida
Florida Hospital
Celebration, Florida, United States, 34747
United States, Pennsylvania
Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Intuitive Surgical
Investigators
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Principal Investigator: Christopher Holsinger, MD Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT03049280     History of Changes
Other Study ID Numbers: ISI dV SP-TORS - 01
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases