Head and Neck Cancers Clinical Trial
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
Verified date | November 2016 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - unexplained fever and/or untreated - active infection - pregnancy - anatomic parameters which preclude transoral surgery, such as: 1. trismus 2. limited range of neck motion 3. poor dentition 4. redundant hypopharyngeal or supraglottic tissue which would prevent adequate visualization of the tumor - participation in a research protocol which precludes participation in other protocols |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure | Six weeks | No | |
Secondary | Average Blood Loss | Blood lost during procedure | Duration of procedure up to two hours | No |
Secondary | Average Operative Time | Average operative time in minutes | Up to four hours (240 minutes) | No |
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