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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00691 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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The protocol needs to be re-designed.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (surgery) | Experimental | Patients undergo robotic-assisted surgery using the da Vinci robot |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | Undergo robotic-assisted surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Complication rates with 95% confidence bounds of +/- 31% or smaller | For 100 days post-surgery | |
| Estimated blood loss | For 100 days post-surgery | |
| Operation duration | At the completion of surgery | |
| Complication rate | For 100 days post-surgery | |
| Demographic and clinical data such as stage, grade and histology | At baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Chen, MD, PhD | City of Hope Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |