Overview

This trial is active, not recruiting.

Conditions head and neck cancer, oropharyngeal cancer, hypopharyngeal cancer, upper aerodigestive tract neoplasms
Treatment da vinci® robotic system
Sponsor University of Alabama at Birmingham
Start date February 2007
End date December 2013
Trial size 170 participants
Trial identifier NCT00473564, F061228004, HNO 0601

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
da vinci® robotic system
Head and Neck Surgery using the da Vinci® Robotic System

Primary Outcomes

Measure
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
time frame: Intraoperatively

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Principal investigator William Carroll, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.