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Robotic-Assisted Surgery in Treating Patients With Spine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345903
Recruitment Status : Withdrawn (The protocol needs to be re-designed.)
First Posted : May 2, 2011
Last Update Posted : November 9, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Adult Spinal Cord Neoplasm Spinal Bone Metastases Spinal Cord Metastases Procedure: therapeutic conventional surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Treatment (surgery)
Patients undergo robotic-assisted surgery using the da Vinci robot
Procedure: therapeutic conventional surgery
Undergo robotic-assisted surgery

Primary Outcome Measures :
  1. Complication rates with 95% confidence bounds of +/- 31% or smaller [ Time Frame: For 100 days post-surgery ]
  2. Estimated blood loss [ Time Frame: For 100 days post-surgery ]
  3. Operation duration [ Time Frame: At the completion of surgery ]
  4. Complication rate [ Time Frame: For 100 days post-surgery ]
  5. Demographic and clinical data such as stage, grade and histology [ Time Frame: At baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345903

Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
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Principal Investigator: Mike Chen, MD, PhD City of Hope Medical Center
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Responsible Party: City of Hope Medical Center Identifier: NCT01345903    
Other Study ID Numbers: 09202
NCI-2011-00691 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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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