NCT00721539

Brief Summary

To assess the use of the da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) in transoral surgeries in patients with benign and malignant lesions of the oral cavity and laryngopharynx.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

November 3, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

July 22, 2008

Results QC Date

November 18, 2014

Last Update Submit

November 2, 2016

Conditions

Hypopharyngeal NeoplasmsLaryngeal NeoplasmsHead and Neck Cancers

Outcome Measures

Primary Outcomes (1)

  • Overall Complication Rate (Intraoperative and Postoperative)

    Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.

    Six weeks

Secondary Outcomes (3)

  • Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure

    Six weeks

  • Average Blood Loss

    Duration of procedure up to two hours

  • Average Operative Time

    Up to four hours (240 minutes)

Study Arms (1)

Transoral Robotic Surgery

OTHER

Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.

Device: da Vinci Surgical Robot PlatformProcedure: Transoral Robotic Surgery

Interventions

da Vinci Surgical Robot PlatformDEVICE

daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.

Transoral Robotic Surgery
Transoral Robotic SurgeryPROCEDURE

Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods.

Transoral Robotic Surgery

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient or volunteer is 18 years of age or older
  • Patients must have indication for diagnosis and/or therapy of diseases of the oropharynx, hypopharynx, and/or larynx.

You may not qualify if:

  • unexplained fever and/or untreated
  • active infection
  • pregnancy
  • anatomic parameters which preclude transoral surgery, such as:
  • trismus
  • limited range of neck motion
  • poor dentition
  • redundant hypopharyngeal or supraglottic tissue which would prevent adequate visualization of the tumor
  • participation in a research protocol which precludes participation in other protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hypopharyngeal NeoplasmsLaryngeal NeoplasmsHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed secondary to low accrual of subjects.

Results Point of Contact

Title
Edward Damrose, MD, associate professor
Organization
Stanford
edamrose@stanford.edu
650-725-6500

Study Officials

  • Edward J. Damrose MD, FACS

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Otolaryngology

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 3, 2016

Results First Posted

November 3, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)