Robotic-Assisted Surgery in Treating Patients With Spine Tumors
|ClinicalTrials.gov Identifier: NCT01345903|
Recruitment Status : Withdrawn (The protocol needs to be re-designed.)
First Posted : May 2, 2011
Last Update Posted : November 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Adult Spinal Cord Neoplasm Spinal Bone Metastases Spinal Cord Metastases||Procedure: therapeutic conventional surgery||Not Applicable|
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 controls.
II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||June 2013|
Experimental: Treatment (surgery)
Patients undergo robotic-assisted surgery using the da Vinci robot
Procedure: therapeutic conventional surgery
Undergo robotic-assisted surgery
- Complication rates with 95% confidence bounds of +/- 31% or smaller [ Time Frame: For 100 days post-surgery ]
- Estimated blood loss [ Time Frame: For 100 days post-surgery ]
- Operation duration [ Time Frame: At the completion of surgery ]
- Complication rate [ Time Frame: For 100 days post-surgery ]
- Demographic and clinical data such as stage, grade and histology [ Time Frame: At baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345903
|Principal Investigator:||Mike Chen, MD, PhD||City of Hope Medical Center|