NCT03049280

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2017

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

August 18, 2020

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

January 30, 2017

Results QC Date

July 28, 2020

Last Update Submit

September 15, 2020

Conditions

Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Positive Surgical Margin

    Through14-days postoperatively

Study Arms (1)

Transoral robotic surgery

EXPERIMENTAL
Device: Transoral robotic surgery

Interventions

Transoral robotic surgeryDEVICE

Transoral robotic surgery for T1 \& T2 oropharyngeal cancers

Transoral robotic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Board of Trustees of the Leland Stanford Junior University

Palo Alto, California, 94304, United States

Location

Florida Hospital

Celebration, Florida, 34747, United States

Location

Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 31536129DERIVED

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Intuitive Surgical Clinical Affairs
Organization
Intuitive Surgical
sylvie.akiel-fu@intusurg.com
408-523-2100

Study Officials

  • Christopher Holsinger, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 10, 2017

Study Start

April 17, 2017

Primary Completion

November 14, 2017

Study Completion

December 26, 2017

Last Updated

October 6, 2020

Results First Posted

August 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)