Overview

This trial is active, not recruiting.

Condition head and neck neoplasms
Treatment da vinci robotic transoral robotic surgical system
Phase phase 0
Sponsor Comprehensive Cancer Center of Wake Forest University
Start date June 2010
End date October 2014
Trial size 60 participants
Trial identifier NCT01059357, CCCWFU 60209

Summary

The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
da vinci robotic transoral robotic surgical system (TORS) Da Vinci Robotic Transoral Robotic Surgical System
(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Primary Outcomes

Measure
In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis.
time frame: 6 months

Secondary Outcomes

Measure
Secondary outcome measures are operative time, blood loss and complications, to assess the learning curve for TORS by measuring the efficiency and accuracy of the procedures, and to assess the quality of life of the patients undergoing TORS.
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx) - Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation Exclusion Criteria: - Unexplained fever and/or untreated, active infection - Patient pregnancy - Previous head and neck surgery precluding transoral/robotic procedures - The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Additional Information

Official title A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
Principal investigator Joshua D. Waltonen, MD
Description Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in July 2016.