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

Sponsor:	University of Alabama at Birmingham
Information provided by (Responsible Party):	Scott Magnuson, MD, 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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:	December 2015
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A 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

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:

Scott Magnuson, MD

University of Alabama at Birmingham

More Information

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dean NR, Rosenthal EL, Carroll WR, Kostrzewa JP, Jones VL, Desmond RA, Clemons L, Magnuson JS. Robotic-assisted surgery for primary or recurrent oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):380-4.

Iseli TA, Kulbersh BD, Iseli CE, Carroll WR, Rosenthal EL, Magnuson JS. Functional outcomes after transoral robotic surgery for head and neck cancer. Otolaryngol Head Neck Surg. 2009 Aug;141(2):166-71.

Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract neoplasms. Arch Otolaryngol Head Neck Surg. 2009 Apr;135(4):397-401.

Responsible Party:	Scott Magnuson, MD, Associate Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00473564 History of Changes
Other Study ID Numbers:	F061228004, HNO 0601
Study First Received:	May 14, 2007
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Lesions
Biopsy
Surgery

ClinicalTrials.gov processed this record on February 08, 2012