Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery - Full Text View

Sponsored by:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00473564

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
Oropharyngeal Lesions Hypopharyngeal Lesions Oral Cavity Lesions	Procedure: da Vinci® Robotic System

U.S. FDA Resources

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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Assess exposure and access to oropharyngeal and hypopharyngeal head and neck lesions [ Time Frame: Post operatively and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of patient safety and document surgical time and set-up [ Time Frame: Post operatively and 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Single Arm using 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

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473564

Contacts

Contact: Lisa Clemons, RN

(205) 934-9714

lkclemons@uabmc.edu

Locations

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

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Principal Investigator:

Eben Rosenthal, MD

University of Alabama at Birmingham

More Information

Responsible Party:	University of Alabama at Birmingham ( Eben Rosenthal, MD )
Study ID Numbers:	F061228004, HNO 0601
Study First Received:	May 14, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00473564
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Lesions
Biopsy
Surgery

Study placed in the following topic categories:

Dental Caries

ClinicalTrials.gov processed this record on January 14, 2009