Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Brief Title

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Official Title

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Brief Summary

      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.
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions

Secondary Outcome

 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.

Condition

Head and Neck Cancer

Intervention

da Vinci® Robotic System

Study Arms / Comparison Groups

 TORS Candidates
Description:  Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

170

Start Date

February 2007

Completion Date

December 2015

Primary Completion Date

December 2013

Eligibility Criteria

        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.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

William Carroll, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00473564

Organization ID

F061228004

Secondary IDs

HNO 0601

Responsible Party

Principal Investigator

Study Sponsor

University of Alabama at Birmingham


Study Sponsor

William Carroll, MD, Principal Investigator, University of Alabama at Birmingham


Verification Date

February 2016