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Robotic-Assisted Surgery in Treating Patients With Spine Tumors

Primary Purpose

Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
therapeutic conventional surgery
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Spinal Cord Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (surgery)

    Arm Description

    Patients undergo robotic-assisted surgery using the da Vinci robot

    Outcomes

    Primary Outcome Measures

    Complication rates with 95% confidence bounds of +/- 31% or smaller
    Estimated blood loss
    Operation duration
    Complication rate
    Demographic and clinical data such as stage, grade and histology

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2011
    Last Updated
    November 8, 2012
    Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01345903
    Brief Title
    Robotic-Assisted Surgery in Treating Patients With Spine Tumors
    Official Title
    A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The protocol needs to be re-designed.
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    June 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    City of Hope Medical Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Metastases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (surgery)
    Arm Type
    Experimental
    Arm Description
    Patients undergo robotic-assisted surgery using the da Vinci robot
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic conventional surgery
    Intervention Description
    Undergo robotic-assisted surgery
    Primary Outcome Measure Information:
    Title
    Complication rates with 95% confidence bounds of +/- 31% or smaller
    Time Frame
    For 100 days post-surgery
    Title
    Estimated blood loss
    Time Frame
    For 100 days post-surgery
    Title
    Operation duration
    Time Frame
    At the completion of surgery
    Title
    Complication rate
    Time Frame
    For 100 days post-surgery
    Title
    Demographic and clinical data such as stage, grade and histology
    Time Frame
    At baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Chen, MD, PhD
    Organizational Affiliation
    City of Hope Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Robotic-Assisted Surgery in Treating Patients With Spine Tumors

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