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Robotic-Assisted Surgery in Treating Patients With Spine Tumors

This study has been withdrawn prior to enrollment.
(The protocol needs to be re-designed.)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center Identifier:
First received: April 28, 2011
Last updated: November 8, 2012
Last verified: November 2012
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

Condition Intervention
Adult Spinal Cord Neoplasm
Spinal Bone Metastases
Spinal Cord Metastases
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: December 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (surgery)
Patients undergo robotic-assisted surgery using the da Vinci robot
Procedure: therapeutic conventional surgery
Undergo robotic-assisted surgery

Detailed Description:


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI)
  • Karnofsky performance status (PS) of >= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1
  • Expected survival greater than 3 months
  • Patient must be able to understand and sign a study-specific informed consent form

Exclusion Criteria:

  • Previous surgery at that specific segment
  • Radiation at that specific spinal segment within the last 2 months
  • Karnofsky PS < 80 or ECOG PS > 1
  • Pregnancy (due to risk of anesthesia)
  • The presence of medical conditions which contraindicate general anesthesia
  • Unexplained fever or untreated, active infection
  • Inability to obtain exposure to allow performance of the planned spine surgical procedure
  • History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
  Contacts and Locations
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Please refer to this study by its identifier: NCT01345903

Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Mike Chen, MD, PhD City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center Identifier: NCT01345903     History of Changes
Other Study ID Numbers: 09202
NCI-2011-00691 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: April 28, 2011
Last Updated: November 8, 2012

Additional relevant MeSH terms:
Neoplasm Metastasis
Spinal Cord Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 26, 2017