Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Head and Neck Cancer Clinical Trial

Official title:

Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473564
• Other study ID #: F061228004
• Secondary ID: HNO 0601
• Status: Completed
• Phase: N/A
• First received: May 14, 2007
• Last updated: February 5, 2016
• Start date: February 2007
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Upper Aerodigestive Tract Neoplasms

Intervention

Procedure:
• da Vinci® Robotic System
Head and Neck Surgery using the da Vinci® Robotic System

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Medical Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions	Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions	Intraoperatively average of 2 hours	No
Secondary	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.	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	3 - 24 months postoperatively	Yes