A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
18 Years
N/A
Both
Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases
Trial Information
A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complication rates with 95% confidence bounds of +/- 31% or smaller
Outcome Time Frame:
For 100 days post-surgery
Safety Issue:
No
Principal Investigator
Mike Chen, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Federal Government
Study ID:
09202
NCT ID:
NCT01345903
Start Date:
December 2012
Completion Date:
Related Keywords:
- Adult Spinal Cord Neoplasm
- Spinal Bone Metastases
- Spinal Cord Metastases
- Neoplasms
- Neoplasm Metastasis
- Spinal Cord Neoplasms
- Bone Neoplasms
- Bone Marrow Diseases
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