NCT01345903

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

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

April 28, 2011

Last Update Submit

November 8, 2012

Conditions

Adult Spinal Cord NeoplasmSpinal Bone MetastasesSpinal Cord Metastases

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Treatment (surgery)

EXPERIMENTAL

Patients undergo robotic-assisted surgery using the da Vinci robot

Procedure: therapeutic conventional surgery

Interventions

therapeutic conventional surgeryPROCEDURE

Undergo robotic-assisted surgery

Treatment (surgery)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mike Chen, MD, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2011

First Posted

May 2, 2011

Study Start

December 1, 2012

Primary Completion

June 1, 2013

Last Updated

November 9, 2012

Record last verified: 2012-11