A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
I. To perform a small pilot study that will demonstrate the feasibility of neurosurgical
spinal procedures using the da Vinci surgical robot.
I. To compare complication rates, operative time and estimated blood loss with historical
II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and
II. Routine imaging of the spinal segment.
Patients undergo robotic-assisted surgery using the da Vinci robot.
After completion of study treatment, patients are followed up for 100 days.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complication rates with 95% confidence bounds of +/- 31% or smaller
For 100 days post-surgery
Mike Chen, MD, PhD
City of Hope Medical Center
United States: Federal Government