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This study has been withdrawn prior to enrollment.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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345903

Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Mike Chen, MD, PhD City of Hope Medical Center
  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 August 20, 2014