NCT00473564

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 30, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

February 1, 2016

Enrollment Period

6.8 years

First QC Date

May 14, 2007

Results QC Date

April 14, 2015

Last Update Submit

February 5, 2016

Conditions

Head and Neck CancerOropharyngeal CancerHypopharyngeal CancerUpper Aerodigestive Tract Neoplasms

Keywords

LesionsBiopsySurgery

Outcome Measures

Primary Outcomes (1)

  • 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

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.

    3 - 24 months postoperatively

Study Arms (1)

TORS Candidates

EXPERIMENTAL

Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System

Procedure: da Vinci® Robotic System

Interventions

da Vinci® Robotic SystemPROCEDURE

Head and Neck Surgery using the da Vinci® Robotic System

TORS Candidates

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Psychological condition that renders the patient unable to understand the informed consent;
  • Poor mouth opening, with maximal opening less than 1.5 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (3)

  • Dean NR, Rosenthal EL, Carroll WR, Kostrzewa JP, Jones VL, Desmond RA, Clemons L, Magnuson JS. Robotic-assisted surgery for primary or recurrent oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):380-4. doi: 10.1001/archoto.2010.40.

    PMID: 20403855DERIVED

  • Iseli TA, Kulbersh BD, Iseli CE, Carroll WR, Rosenthal EL, Magnuson JS. Functional outcomes after transoral robotic surgery for head and neck cancer. Otolaryngol Head Neck Surg. 2009 Aug;141(2):166-71. doi: 10.1016/j.otohns.2009.05.014.

    PMID: 19643246DERIVED

  • Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract neoplasms. Arch Otolaryngol Head Neck Surg. 2009 Apr;135(4):397-401. doi: 10.1001/archoto.2009.24.

    PMID: 19380364DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsOropharyngeal NeoplasmsHypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
William Carroll, MD
Organization
University of Alabama at Birmingham
wcarroll@uabmc.edu
205-934-9767

Study Officials

  • William Carroll, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

March 8, 2016

Results First Posted

April 30, 2015

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)