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A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms

Thank you

Trial Information

A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery


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).22 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.


Inclusion Criteria:



- At least 18 years f age

- Indications for diagnostic or therapeutic approaches for benign or malignant disease
of the head and neck

- Written informed consent

Exclusion Criteria:

- Unexplained fever and/or untreated, active infection

- Pregnancy

- Previous head and neck surgery precluding transoral/endoscopic/robotic procedures

- Presence of medical conditions contraindicating general anesthesia or transoral
surgical approaches

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

ability to adequately visualize the operative field and complete planned surgery

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Richard V Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Institutional Review Board

Study ID:

07-03-080

NCT ID:

NCT00627562

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Head and Neck Neoplasms
  • robotic
  • robot assisted
  • minimally invasive
  • tumors of head and neck
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490