Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00473564
First received: May 14, 2007
Last updated: April 14, 2015
Last verified: April 2015

May 14, 2007
April 14, 2015
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Active Comparator: 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.
 
Active, not recruiting
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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00473564
F061228004, HNO 0601
Yes
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
April 2015

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