Spinal Bone Metastases Clinical Trial
Official title:
A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery
PRIMARY OBJECTIVES:
I. To perform a small pilot study that will demonstrate the feasibility of neurosurgical
spinal procedures using the da Vinci surgical robot.
SECONDARY OBJECTIVES:
I. To compare complication rates, operative time and estimated blood loss with historical
controls.
II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and
hardware failure.
II. Routine imaging of the spinal segment.
OUTLINE:
Patients undergo robotic-assisted surgery using the da Vinci robot.
After completion of study treatment, patients are followed up for 100 days.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01308489 -
Minimally Invasive Surgery in Treating Patients With Spinal Tumors
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N/A | |
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