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A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms

Thank you

Trial Information

A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System


Patients are going to be evaluated in their usual regular clinical follow ups starting with
preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of
Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).


Inclusion Criteria:



- Patient must present with indications for diagnostic or therapeutic approaches for
benign and malignant diseases of the oral cavity or laryngopharynx (including the
neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate,
posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)

- Patients must have adequate transoral exposure of the oral cavity and laryngopharynx
for TORS instrumentation

Exclusion Criteria:

- Unexplained fever and/or untreated, active infection

- Patient pregnancy

- Previous head and neck surgery precluding transoral/robotic procedures

- The presence of medical conditions contraindicating general anesthesia or transoral
surgical approaches

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Joshua D. Waltonen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 60209

NCT ID:

NCT01059357

Start Date:

June 2010

Completion Date:

January 2016

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157