NCT02002845

A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 285 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System

Interventions

Type	Name	Description
DEVICE	robotic surgery using the da Vinci Surgical System

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-12-06
• Last updated: 2015-12-10

Locations

3 sites across 1 country: United States