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Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Carroll, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00473564
First received: May 14, 2007
Last updated: October 9, 2014
Last verified: October 2014
  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
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: William Carroll, 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):
Responsible Party: William Carroll, MD, 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: October 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Lesions
Biopsy
Surgery

ClinicalTrials.gov processed this record on November 20, 2014