Robotic-Assisted Surgery in Treating Patients With Spine Tumors

November 8, 2012 updated by: City of Hope Medical Center

A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (surgery)
Patients undergo robotic-assisted surgery using the da Vinci robot
Procedure: therapeutic conventional surgery
Undergo robotic-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complication rates with 95% confidence bounds of +/- 31% or smaller
Time Frame: For 100 days post-surgery
For 100 days post-surgery
Estimated blood loss
Time Frame: For 100 days post-surgery
For 100 days post-surgery
Operation duration
Time Frame: At the completion of surgery
At the completion of surgery
Complication rate
Time Frame: For 100 days post-surgery
For 100 days post-surgery
Demographic and clinical data such as stage, grade and histology
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mike Chen, MD, PhD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09202
  • NCI-2011-00691 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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