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Title   A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
Disease/Condition   Head and Neck Cancer
Description   The purpose of this study to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate while using the DaVinci robotic surgical system (Intuitive Surgical, Inc.).

The secondary objectives include evaluation of blood loss, length of hospital stay, complications while using the DaVinci robot system, and quality of life in subjects and historical controls undergoing similar surgery without the robot or radiation therapy.

The study will evaluate recurrence, survival and other outcome data in robotic surgery patients compared with similar historical control groups (matched with respect to stage, prior and subsequent treatment, age, tumor HPV positivity) of patients who have undergone standard surgery without the robot or radiation/chemoradiation treatment as an alternative to surgery.


Eligibility Criteria   To be eligible for this study, patients must meet several criteria, including but not limited to the following:

* Patient must be 18 years or older.

* Indications for diagnostic or therapeutic approaches for benign or malignant disease of the head and neck.
Principal Investigator   Richard Smith, MD
Contact Name   Catherine Sarta, RN
Phone   (718) 920-7054
Contact Email   csarta@montefiore.org
Post Date   02/05/2008
Protocol Number   07-03-080/West
Status   Recruiting
Current Trial Type   Interventional
Montefiore Clinical Trial   No
CHAM Clinical Trial   No