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OpenTrials
Completed

NCT Number: NCT02792322

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device

Device

Patient's will be having TORS surgery in a seated position

Other names: Da Vinci Robotic Surgical Systems

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2016
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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