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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00473564 |
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.
Condition | Intervention |
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Oropharyngeal Lesions Hypopharyngeal Lesions Oral Cavity Lesions |
Procedure: da Vinci® Robotic System |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery |
Estimated Enrollment: | 40 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Single Arm using da Vinci Robotic System
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Procedure: da Vinci® Robotic System
Head and Neck Surgery using the da Vinci® Robotic System
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Clemons, RN | (205) 934-9714 | lkclemons@uabmc.edu |
United States, Alabama | |
University of Alabama at Birmingham Medical Center | Recruiting |
Birmingham, Alabama, United States, 35233 | |
Contact: Lisa Clemons, RN, BSN 205-934-9714 lkclemons@uabmc.edu | |
Principal Investigator: Eben Rosenthal, MD | |
Sub-Investigator: William Carroll, MD | |
Sub-Investigator: Scott Magnuson, MD |
Principal Investigator: | Eben Rosenthal, MD | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Eben Rosenthal, MD ) |
Study ID Numbers: | F061228004, HNO 0601 |
Study First Received: | May 14, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00473564 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lesions Biopsy Surgery |