May 14, 2007 |
February 12, 2009 |
February 2007 |
Assess exposure and access to oropharyngeal and hypopharyngeal head and neck lesions [ Time Frame: Post operatively and 3 months ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00473564 on ClinicalTrials.gov Archive Site |
Assessment of patient safety and document surgical time and set-up [ Time Frame: Post operatively and 3 months ] [ Designated as safety issue: Yes ] |
Same as current |
|
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery |
Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery |
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. |
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. |
|
Interventional |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
- Oropharyngeal Lesions
- Hypopharyngeal Lesions
- Oral Cavity Lesions
|
Procedure: da Vinci® Robotic System |
Active Comparator: Single Arm using da Vinci Robotic System |
Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract neoplasms. Arch Otolaryngol Head Neck Surg. 2009 Apr;135(4):397-401. |
|
Recruiting |
40 |
February 2010 |
December 2009 (final data collection date for primary outcome measure) |
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.
|
Both |
20 Years and older |
No |
|
United States |
|
|
NCT00473564 |
Eben Rosenthal, MD, University of Alabama at Birmingham |
HNO 0601 |
University of Alabama at Birmingham |
|
Principal Investigator: |
Eben Rosenthal, MD |
University of Alabama at Birmingham |
|
|
University of Alabama at Birmingham |
February 2009 |