A Pilot Study of the Use of the DaVinci Robotic System for Otorhinolaryngology-Head and Neck Surgery
Status unconfirmed · Not applicable
Conditions studied: Head and Neck Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00627562
- Run by
- Montefiore Medical Center
- People needed
- 71
- Starts
- 2007-07-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2016-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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