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NCT Number: NCT00473564

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Hypopharyngeal Cancer Hypopharyngeal Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Cancer Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Upper Aerodigestive Tract Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

da Vinci® Robotic System

Procedure

Head and Neck Surgery using the da Vinci® Robotic System

Primary outcomes

  1. Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions

    Time frame: Intraoperatively average of 2 hours

    Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions

Secondary outcomes

  1. 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

    Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2015
First posted
May 15, 2007
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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