An observational study in Subjects Who Have Undergone Benign Non-tumor TORS Procedures Using the da Vinci Surgical System, sponsored by Intuitive Surgical. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-10.
Sponsored by Intuitive Surgical · Observational
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.
Primary Effectiveness Endpoint:
Safety Endpoint:
Assessment of adverse events through post-operative follow-up including but not limited to:
▪ Mortality
Additional endpoints evaluated may include:
Intuitive Surgical is the lead sponsor of 62 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System
Exclusion Criteria:
Patient who have undergone benign non-tumor TORS procedures using the da Vinci Surgical System
Device: robotic surgery using the da Vinci Surgical System
Primary Effectiveness Endpoint
Ability to complete procedure without a need for conversion to a non-robotic approach
Time frame: intra-operative
Primary Safety endpoint
Assessment of adverse events through post-operative follow-up including but not limited to: • Bleeding ▪ Mortality
Time frame: up to 30 days after surgery
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Intuitive Surgical