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

NCT00627562 · Montefiore Medical Center · Updated 17 March 2016

What is being tested
robot assisted endoscopic head and neck surgery using the DaVinci Robotic Surgical System
For
Head and Neck Neoplasms
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 71 people. The full rules are on the registry page.
Where
United States
When
Starts or started July 2007, ends Dec 2017. Registered 3 March 2008.
Results
None posted yet.

In the researchers' words

1. Patients included will have benign or malignant lesions with treatment plan for endoscopic resection or resection by other minimally invasive techniques. 2. They will be offered a robotic approach to their surgery using the DaVinci robotic surgical system (intuitive Surgical, Inc.). 3. The objectives are to evaluate our ability to adequately visualize the surgical field and perform the intended surgery without a higher complication rate. 4. Secondary objective 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. 5. To 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. 5\. Endpoints will be compared to historical controls.
ClinicalTrials.gov, NCT00627562

Sites

  • Montefiore Medical CenterThe Bronx, New York, United States