Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 14, 2007

Last Updated Date

February 12, 2009

Start Date ^†

February 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00473564 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Oropharyngeal Lesions
Hypopharyngeal Lesions
Oral Cavity Lesions

Intervention ^†

Procedure: da Vinci® Robotic System

Study Arms / Comparison Groups

Active Comparator: Single Arm using da Vinci Robotic System

Publications *

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.

* 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 ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

February 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

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

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Lisa Clemons, RN

(205) 934-9714

lkclemons@uabmc.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00473564

Responsible Party

Eben Rosenthal, MD, University of Alabama at Birmingham

Secondary IDs ^††

HNO 0601

Study Sponsor ^†

University of Alabama at Birmingham

Collaborators ^††

Investigators ^†

Principal Investigator:

Eben Rosenthal, MD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.