Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-01 @ 6:42 PM
Study NCT ID:
NCT01345903
Status:
WITHDRAWN
Last Update Posted:
2012-11-09
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic-Assisted Surgery in Treating Patients With Spine Tumors
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
Status:
WITHDRAWN
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The protocol needs to be re-designed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-00691 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |