Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
This trial is active, not recruiting.
|Conditions||head and neck cancer, oropharyngeal cancer, hypopharyngeal cancer, upper aerodigestive tract neoplasms|
|Treatment||da vinci® robotic system|
|Sponsor||University of Alabama at Birmingham|
|Start date||February 2007|
|End date||December 2013|
|Trial size||170 participants|
|Trial identifier||NCT00473564, F061228004, HNO 0601|
To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
time frame: Intraoperatively
Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
time frame: 3 - 24 months postoperatively
Male or female participants at least 20 years old.
Inclusion Criteria: - Head and neck lesions requiring surgical resection, biopsy, or invasive treatment; - Lesion amendable to robotic assisted surgery treatment; - Age > 19 years; - Patient must sign informed consent. Exclusion Criteria: - Psychological condition that renders the patient unable to understand the informed consent; - Poor mouth opening, with maximal opening less than 1.5 cm.
|Official title||Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery|
|Principal investigator||William Carroll, MD|
|Description||This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.|
Call for more information