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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
  Purpose
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
Head and Neck Cancer Oropharyngeal Cancer Hypopharyngeal Cancer Upper Aerodigestive Tract Neoplasms Procedure: da Vinci® Robotic System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Resource links provided by NLM:


Further study details as provided by William Carroll, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 170
Study Start Date: February 2007
Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TORS Candidates
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
Procedure: da Vinci® Robotic System
Head and Neck Surgery using the da Vinci® Robotic System

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473564


Locations
United States, Alabama
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: William Carroll, MD University of Alabama at Birmingham
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Carroll, MD, Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00473564     History of Changes
Other Study ID Numbers: F061228004
HNO 0601 ( Other Identifier: UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee )
First Submitted: May 14, 2007
First Posted: May 15, 2007
Results First Submitted: April 14, 2015
Results First Posted: April 30, 2015
Last Update Posted: March 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by William Carroll, MD, University of Alabama at Birmingham:
Lesions
Biopsy
Surgery

Additional relevant MeSH terms:
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Hypopharyngeal Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases