A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures
Overview
A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.
Full Title of Study: “A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: February 2014
Detailed Description
Primary Effectiveness Endpoint: • Ability to complete procedure without a need for conversion to a non-robotic approach Safety Endpoint: Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality Additional endpoints evaluated may include: – Procedure times – Length of hospital stay – Volume of tissue resected – Use of tissue sealants
Interventions
- Device: robotic surgery using the da Vinci Surgical System
Arms, Groups and Cohorts
- Robotic arm
- Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System
Clinical Trial Outcome Measures
Primary Measures
- Primary Effectiveness Endpoint
- Time Frame: intra-operative
- Ability to complete procedure without a need for conversion to a non-robotic approach
- Primary Safety endpoint
- Time Frame: up to 30 days after surgery
- Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality
Participating in This Clinical Trial
Inclusion Criteria
- The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure. – Subject was ≥18 years of age at the time of procedure Exclusion Criteria:
- Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy. – Subject underwent a TORS procedure for oropharyngeal cancer
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Intuitive Surgical
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Shilpa Mehendale, MS, Study Director, Intutive Surgical
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