Robotic-Assisted Surgery in Treating Patients With Spine Tumors

Spinal Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01345903
• Other study ID #: 09202
• Secondary ID: NCI-2011-00691
• Status: Withdrawn
• Phase: N/A
• First received: April 28, 2011
• Last updated: November 8, 2012
• Start date: December 2012

Study information

• Verified date: November 2012
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Spinal Cord Neoplasm
• Neoplasm Metastasis
• Spinal Bone Metastases
• Spinal Cord Metastases
• Spinal Cord Neoplasms

Intervention

Procedure:
• therapeutic conventional surgery
Undergo robotic-assisted surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rates with 95% confidence bounds of +/- 31% or smaller		For 100 days post-surgery	No
Primary	Estimated blood loss		For 100 days post-surgery	No
Primary	Operation duration		At the completion of surgery	No
Primary	Complication rate		For 100 days post-surgery	No
Primary	Demographic and clinical data such as stage, grade and histology		At baseline	No