Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System

NCT01059357 | Completed Results DMC FDA Device

• 2 other identifiers: IRB00009802CCCWFU 60209
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.

  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

  At time of surgery, lasting up to 3 hours. Assessed for up to 6 months

Secondary Outcomes (5)

• Operative Time

  At time of surgery, up to 3 hours

• Number of Participants With Blood Loss and Complications

  6 months

• Average Time to Set up and Perform Procedures

  At time of surgery, up to 3 hours

• Number of Correctly Predicted Success of TORS Preoperatively

  preoperative

• QOL

  6 months

Study Arms (1)

Transoral Robotic Surgery (TORS)

EXPERIMENTAL

Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System

Device: Da Vinci Robotic Transoral Robotic Surgical System

Interventions

Da Vinci Robotic Transoral Robotic Surgical System DEVICE

(TORS) Da Vinci Robotic Transoral Robotic Surgical System

Also known as: (TORS) Da Vinci Robotic Transoral Robotic Surgical System

Transoral Robotic Surgery (TORS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr. Joshua Waltonen
• Organization: Wake Forest University Health Sciences

jwaltone@wakehealth.edu

3367169068

Study Officials

• Joshua D. Waltonen, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 29, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 16, 2018
• Results First Posted: November 16, 2018

Record last verified: 2018-11

Locations

US (1)