Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
This study is currently recruiting participants.
Verified January 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01059357
First received: January 21, 2010
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Neoplasms |
Device: Da Vinci Robotic Transoral Robotic Surgical System |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System |
Resource links provided by NLM:
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary outcome measures are operative time, blood loss and complications, to assess the learning curve for TORS by measuring the efficiency and accuracy of the procedures, and to assess the quality of life of the patients undergoing TORS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transoral Robotic Surgery (TORS)
Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
|
Device: Da Vinci Robotic Transoral Robotic Surgical System
(TORS) Da Vinci Robotic Transoral Robotic Surgical System
Other Name: (TORS) Da Vinci Robotic Transoral 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059357
Contacts
| Contact: Joshua D. Waltonen, MD | 336-716-8964 | jwaltone@wfubmc.edu |
Locations
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Waltonen jwaltone@wfubmc.edu | |
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
| Principal Investigator: | Joshua D. Waltonen, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01059357 History of Changes |
| Other Study ID Numbers: | CCCWFU 60209 |
| Study First Received: | January 21, 2010 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Head and Neck Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on June 17, 2013