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Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System (TORS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059357
First Posted: January 29, 2010
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention Phase
Head and Neck Neoplasms Device: Da Vinci Robotic Transoral Robotic Surgical System Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 58
Actual Study Start Date: June 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transoral Robotic Surgery (TORS)
Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
Device: Da Vinci Robotic Transoral Robotic Surgical System
(TORS) Da Vinci Robotic Transoral Robotic Surgical System
Other Name: (TORS) Da Vinci Robotic Transoral Robotic Surgical System

Detailed 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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059357


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Joshua D. Waltonen, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01059357     History of Changes
Other Study ID Numbers: CCCWFU 60209
First Submitted: January 21, 2010
First Posted: January 29, 2010
Last Update Posted: August 2, 2017
Last Verified: July 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms