Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System
Conditions
Keywords
Tongue base resection, partial glossectomy
Brief summary
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.
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
DEVICErobotic surgery using the da Vinci Surgical System
Sponsors
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | intra-operative | Ability to complete procedure without a need for conversion to a non-robotic approach |
| Primary Safety endpoint | up to 30 days after surgery | Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality |
Countries
United States
Outcome results
None listed