Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck

May 30, 2025 updated by: Kathryn (Katie) M. Van Abel, Mayo Clinic

A Pilot Study Assessing Robotic Surgery in the Seated or Supine Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical Systems and Modified Transoral Instrumentation

This study is designed to investigate if transoral surgery with the patient in the seated position utilizing the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) will enable better visualization and expedited removal of benign and malignant tumors of the throat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) being evaluated in this pilot study consists of 3 basic components: a surgeon's console, articulated mechanical arms and sterilizable instruments. The console includes a computer, video monitor and instrument controls, and is located in the operating room adjacent to the operating room table. The console is connected via computer to the mechanical arms holding the endoscope (surgical TV camera) and sterile surgical tools (e.g., forceps, scissors, electrocautery, etc.). These arms are located immediately adjacent to the patient on the operating room table. The surgeon sits at the console and controls the position and movement of the arms and surgical tools. The design of these tools is based upon well-established, commonly used surgical instruments. The da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a "manual image-guided surgery" system that is computer enhanced rather than "computer guided robotic surgery" in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a "milling" device). Use of the da Vinci Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in the aforementioned configuration in fact facilitates an exact translation of the surgeon's hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient must present with indications for diagnostic or therapeutic surgery for benign or malignant diseases of the head and neck.
  • Written informed consent.

Pre-Operative Exclusion Criteria:

  • Unexplained fever and/or untreated, active infection.
  • Patient pregnancy.
  • Previous head and neck surgery precluding robotic procedures.
  • The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.

Intra-Operative Exclusion Criteria:

  • It is recognized that sometimes patients cannot be excluded from study participation until prepped in the surgical suite such that their anatomy is exposed and available for medical analysis. The following situations represent instances whereby which patients would be excluded from this study based upon anatomical findings not evident in the pre-operative setting:
  • Inability to adequately visualize anatomy or place robotic instrumentation to perform the diagnostic or therapeutic surgical approach in the seated position.
  • In this circumstance, the procedure would be completed by standard robotic transoral surgery or an alternative approach may be chosen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Trans Oral Robotic Surgery (TORS)
Patient's are having TORS surgery in a seated position
Device: Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device
Patient's will be having TORS surgery in a seated position
Other Names:
  • Da Vinci Robotic Surgical Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TORS surgery completion in the seated position
Time Frame: Measures assessed at time of intervention (during surgery)
Recording how many participants' surgery was completed in the seated position
Measures assessed at time of intervention (during surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of participants' surgical time
Time Frame: Measures assessed at time of intervention (during surgery)
Surgical start and stop times are recorded in the medical record
Measures assessed at time of intervention (during surgery)
Estimated amount of blood loss during participants' surgery
Time Frame: Measures assessed at time of intervention (during surgery)
Record blood loss during surgery as estimated by the lead surgeon
Measures assessed at time of intervention (during surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kathryn Van Abel, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2016

Primary Completion (Actual)

May 7, 2024

Study Completion (Actual)

May 7, 2024

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimated)

June 7, 2016

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001297
  • NCI-2022-10968 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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