Robotic-Assisted Surgery in Treating Patients With Spine Tumors
This study has been withdrawn prior to enrollment.
(The protocol needs to be re-designed.)
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01345903
First received: April 28, 2011
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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 | Intervention |
|---|---|
|
Adult Spinal Cord Neoplasm Spinal Bone Metastases Spinal Cord Metastases |
Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors |
Resource links provided by NLM:
Further study details as provided by City of Hope Medical Center:
Primary Outcome Measures:
- Complication rates with 95% confidence bounds of +/- 31% or smaller [ Time Frame: For 100 days post-surgery ] [ Designated as safety issue: No ]
- Estimated blood loss [ Time Frame: For 100 days post-surgery ] [ Designated as safety issue: No ]
- Operation duration [ Time Frame: At the completion of surgery ] [ Designated as safety issue: No ]
- Complication rate [ Time Frame: For 100 days post-surgery ] [ Designated as safety issue: No ]
- Demographic and clinical data such as stage, grade and histology [ Time Frame: At baseline ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (surgery)
Patients undergo robotic-assisted surgery using the da Vinci robot
|
Procedure: therapeutic conventional surgery
Undergo robotic-assisted surgery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT01345903 History of Changes |
| Other Study ID Numbers: | 09202, NCI-2011-00691 |
| Study First Received: | April 28, 2011 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Neoplasm Metastasis Spinal Cord Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013