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Clinical Trials/NCT01059357
NCT01059357CompletedNot Applicable

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

Wake Forest University Health Sciences2 sites in 1 country58 target enrollmentStarted: June 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
2
Primary Endpoint
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Transoral Robotic Surgery (TORS)

Experimental

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

Intervention: Da Vinci Robotic Transoral Robotic Surgical System (Device)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Transoral Robotic Surgery (TORS) for Oral... | Clinical Trial