Robotic-Assisted Surgery in Treating Patients With Spine Tumors
NCT ID: NCT01345903
Last Updated: 2012-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (surgery)
Patients undergo robotic-assisted surgery using the da Vinci robot
therapeutic conventional surgery
Undergo robotic-assisted surgery
Interventions
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therapeutic conventional surgery
Undergo robotic-assisted surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Mike Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Countries
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Other Identifiers
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NCI-2011-00691
Identifier Type: REGISTRY
Identifier Source: secondary_id
09202
Identifier Type: -
Identifier Source: org_study_id