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Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473564
First Posted: May 15, 2007
Last Update Posted: March 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
May 14, 2007
May 15, 2007
April 14, 2015
April 30, 2015
March 8, 2016
February 2007
December 2013   (Final data collection date for primary outcome measure)
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions [ Time Frame: Intraoperatively average of 2 hours ]
Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
Assess exposure and access to oropharyngeal and hypopharyngeal head and neck lesions
Complete list of historical versions of study NCT00473564 on ClinicalTrials.gov Archive Site
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 ]
Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins
Assessment of patient safety and document surgical time and set-up
Not Provided
Not Provided
 
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
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Oropharyngeal Cancer
  • Hypopharyngeal Cancer
  • Upper Aerodigestive Tract Neoplasms
Procedure: da Vinci® Robotic System
Head and Neck Surgery using the da Vinci® Robotic System
Experimental: TORS Candidates
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Intervention: Procedure: da Vinci® Robotic System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
December 2015
December 2013   (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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00473564
F061228004
HNO 0601 ( Other Identifier: UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee )
Yes
Not Provided
Plan to Share IPD: No
William Carroll, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: William Carroll, MD University of Alabama at Birmingham
University of Alabama at Birmingham
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP